news – page 20 – eisai china lnc.-pg电子app

tokyo and stamford, conn. – march 12, 2019 – eisai co., ltd. (ceo: haruo naito, “eisai”) and imbrium therapeutics l.p. (imbrium therapeutics), a clinical-stage biopharmaceutical company and operating subsidiary of purdue pharma, l.p. (president and ceo: craig landau, md) today announced that the u.s. food and drug administration (fda) has accepted for review the new drug application (nda) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. a prescription drug user fee act (pdufa) date is set for december 27, 2019.

the nda submission was based on data from the clinical development program including two pivotal phase 3 studies of lemborexant – sunrise 1 (study 304) and sunrise 2 (study 303).

• sunrise 1: a one-month phase 3 clinical study to evaluate the efficacy and safety of lemborexant versus placebo and versus an active comparator (zolpidem tartrate extended release, “zolpidem er”) in 1,006 patients 55 years and older (45 percent of all patients were aged 65 years and older) with insomnia disorder. this study assessed sleep latency (using latency to persistent sleep; primary objective); sleep efficiency and wake after sleep onset (effect on maintaining sleep; key secondary objectives) objectively using polysomnography, and achieved its primary and key secondary objectives. the most common adverse events (aes) reported in the lemborexant arms were headache and somnolence.¹

• sunrise 2: a 12-month placebo-controlled (first six months) phase 3 clinical study to evaluate the long-term efficacy and safety of lemborexant in 949 adult patients (18 to 88 years of age) with insomnia disorder. this study evaluated subjective (patient-reported) sleep onset latency (primary objective), sleep efficiency, and wake after sleep onset (key secondary objectives) using sleep diaries, and achieved its pre-specified primary and key secondary efficacy objectives. the most common aes reported in the lemborexant arms were somnolence, nasopharyngitis, headache, and influenza.²

“our ultimate goal for the development of a sleep-wake treatment is to bring to patients living with insomnia a new option that has the potential to improve their ability to fall asleep, stay asleep and wake the next morning without impairment,” said lynn kramer, md, chief clinical officer and chief medical officer, neurology business group, eisai. “this milestone for lemborexant brings us one step closer to addressing unmet needs for millions of patients who experience insomnia.”

“insomnia, a disorder of sleep quality and quantity, causes significant impairment in daily functioning and has long-term consequences for health and well-being,”³ said john renger, phd, vice president, head of research & development and regulatory affairs, imbrium therapeutics. “we are committed to working with our partner eisai to make this investigational treatment available to patients, pending regulatory approval.”

lemborexant is being jointly developed by eisai and imbrium therapeutics for the treatment of multiple sleep-wake disorders, including insomnia disorder. information about ongoing clinical studies is available at clinicaltrials.gov.

eisai and imbrium therapeutics are striving to address new unmet medical needs and to improve the lives of patients and their families.

this release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

contacts:
eisai co., ltd.                                                     imbrium therapeutics l.p.
public relations department                              
81-(0)3-3817-5120

1. about lemborexant
lemborexant is a novel investigational small molecule compound, discovered and developed by eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). in individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. in individuals with sleep-wake disorders, it is possible that orexin signaling that regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep. eisai and imbrium therapeutics are investigating lemborexant as a potential treatment option for multiple sleep-wake disorders, such as insomnia. additionally, a phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder (iswrd) and mild to moderate alzheimer’s dementia is underway.

2. about sunrise 1 (study 304)¹
sunrise 1 was a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study evaluating the efficacy and safety of lemborexant in 1,006 male or female adult patients 55 years and older (45 percent of patients were 65 years and older) with insomnia disorder conducted in north america and europe. sunrise 1 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a 30-day treatment period and a minimum two-week period without treatment prior to the end-of-study visit. in this study, patients were randomized to receive placebo or one of three treatment regimens (lemborexant 5 mg, lemborexant 10 mg, zolpidem er 6.25 mg).

the primary objective for sunrise 1 was to demonstrate using polysomnography that lemborexant at either the 5 mg or 10 mg dose is superior to placebo on objective sleep onset, as measured by latency to persistent sleep after the last two nights of one month of treatment. key secondary objectives included change from baseline in sleep efficiency and wake after sleep onset (waso) for both lemborexant doses compared to placebo, and waso in the second half of the night (waso2h) for both lemborexant doses compared to zolpidem er, each after the last two nights of one month of treatment.

3. about sunrise 2 (study 303)²
sunrise 2 was a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group study of the efficacy and safety of lemborexant in 949 male or female adult participants 18 to 88 years of age with insomnia disorder. sunrise 2 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a six-month placebo-controlled treatment period, a six-month period of active-only treatment and a two-week period without treatment prior to the end-of-study visit. in this study, during the placebo-controlled treatment period, patients were randomized to receive placebo or one of two treatment regimens (lemborexant 5 mg or 10 mg). during the active-only treatment period, patients who received placebo during the first period were re-randomized to receive lemborexant 5 mg or 10 mg. patients who received active treatment during the first period continued on the treatment to which they were originally randomized.

the primary objective was change from baseline in subjective sleep onset latency after six months of placebo-controlled treatment using patient reported (subjective) sleep diaries. key secondary endpoints were change from baseline in subjective sleep efficiency and subjective wake after sleep onset (swaso) by using patient reported (subjective) sleep diaries for both lemborexant doses after six months of placebo-controlled treatment.

4. about sleep disorders
population studies show that sleep disorders affect many more people worldwide than previously thought.⁴ insomnia disorder is the most common sleep disorder affecting approximately 30 percent of the adult population worldwide.^4,5 insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, which can lead to daytime consequences such as fatigue, difficulty concentrating and irritability.^3,6

sleeping well is essential for good health, including brain health. poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke and dementia, as well as adverse effects on mood and behavior.^3,7

experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality.⁸ studies suggest an optimal sleep duration between seven and eight hours.⁹

women are 1.4 times more likely than men to suffer from insomnia.¹⁰ older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking and early waking, that can lead to less sleep time.¹¹

5. about eisai co., ltd
eisai co., ltd. is a leading global research and development-based pharmaceutical company headquartered in japan. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. with over 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including neurology and oncology. furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries. for more information about eisai co., ltd., please visit .

6. about imbrium therapeutics
imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new pharmacologic and biologic therapeutics. we are pursuing treatments for disorders of the central nervous system, oncology chemotherapeutics, and non-opioid approaches to the management of pain. as an operating subsidiary of purdue pharma l.p., imbrium strives to develop and bring to market new medicines that serve the unmet needs of patients, physicians, and health systems worldwide. we have built a robust and diversified pipeline of investigational drug candidates, and we actively collaborate with industry and academic partners to identify and advance future impactful medicines. for more information, please visit .

references
¹ eisai inc. a multicenter, randomized, double-blind, placebo-conrolled, active comparator, parallel-group study of the efficacy and safety of lemborexant in subjects 55 years and older with insomnia disorder. (e2006-g000-304). (clinicaltrials.gov identifier nct02783729). 2018. unpublished data on file.
² eisai inc. a long-term multicenter, randomized, double-blind, controlled, parallel-group study of the safety and efficacy of lemborexant in subjects with insomnia disorder (e2006-g000-303). (clinicaltrials.gov identifier nct02952820). 2018. unpublished data on file.
³ institute of medicine. sleep disorders and sleep deprivation: an unmet public health problem. washington, dc: national academies press. 2006.
⁴ ferrie je, et al. sleep epidemiology – a rapidly growing field. int j epidemiol. 2011;40(6):1431–1437.
⁵ roth t. insomnia: definition, prevalence, etiology and consequences. j clin sleep med. 2007;3(5 suppl):s7–s10.
⁶ ohayon mm, et al. epidemiology of insomnia: what we know and what we still need to learn. sleep med rev. 2002;6(2):97-111.
⁷ pase mp, himali jj, grima na, et al. sleep architecture and the risk of incident dementia in the community. neurology. 2017;89(12):1244-1250.
⁸ cappuccio fp et al. sleep and cardio-metabolic disease. curr cardiol rep. 2017;19:110.
⁹ cappuccio fp et al. sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. sleep. 2010;33(5):585-592.
¹⁰ roth t, et al. prevalence and perceived health associated with insomnia based on dsm-iv-tr; international statistical classification of diseases and related health problems, tenth revision; and research diagnostic criteria/international classification of sleep disorders, second edition criteria: results from the america insomnia survey. biol psychiatry. 2011;69:592– 600.
¹¹ crowley, k. sleep and sleep disorders in older adults. neuropsychol rev. 2011;21(1):41-53.

six-month data show significant improvements in patient-reported measures of sleep onset and sleep maintenance for investigational agent lemborexant

tokyo and stamford, conn. – february 4, 2019 – eisai co., ltd. (ceo: haruo naito, “eisai”) and purdue pharma l.p. (president and ceo: craig landau, md, “purdue pharma”) today announced six-month results from sunrise 2, a long-term phase 3 clinical study evaluating the efficacy and safety of lemborexant, an investigational agent being developed for the treatment of insomnia, a sleep-wake disorder. data were presented at the sleep research society’s advances in sleep and circadian science conference, taking place in clearwater beach, florida, feb. 1-4, 2019.

sunrise 2 was a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group study of the efficacy and safety of lemborexant in 949 adult patients (18 to 88 years of age) with insomnia disorder, which was characterized by difficulty falling asleep and/or staying asleep. approximately 28 percent of the patients randomized and treated were 65 years of age or older. during the first six months of the study, patients were randomized to receive either lemborexant 5 mg, lemborexant 10 mg, or placebo. the primary and key secondary efficacy objectives were assessed by patient self-reports via electronic sleep diaries.

at the end of the six-month, placebo-controlled treatment period, treatment with lemborexant at either 5 mg or 10 mg resulted in statistically significant improvements compared to placebo in patient-reported (subjective) sleep onset latency (ssol), the study’s primary efficacy endpoint, and subjective sleep efficiency (sse) and subjective wake after sleep onset (swaso), the study’s key secondary endpoints. six-month results from the study showed that:
● median reductions from baseline in ssol with lemborexant 5 mg (–21.81 minutes) and 10 mg (–28.21 minutes) were larger and statistically significant compared to placebo (–11.43 minutes) at the end of month six (p<0.0001 for all treatment groups).
● improvements from baseline, as measured by least squares mean (lsm), in sse with lemborexant 5 mg (14.19 percent, p=0.0001) and 10 mg (14.31 percent, p<0.0001) were larger and statistically significant compared to placebo (9.64 percent) at the end of month six.
● reductions from baseline in swaso, as measured by lsm, with lemborexant 5 mg (–46.75 minutes, p=0.0005) and 10 mg (–41.95 minutes, p=0.0105) were larger and statistically significant compared with placebo (–29.28 minutes) at the end of month six.

most adverse events (aes) reported were mild to moderate. serious aes were reported at a rate of 2.2 percent (lemborexant 5 mg), and 2.9 percent (lemborexant 10 mg), and 1.6 percent (placebo); only one was considered treatment-related. the most common aes reported, greater than 5 percent in either lemborexant treatment arm and greater than placebo, were somnolence, headache, and influenza. discontinuation rates due to aes were comparable between placebo and lemborexant 5 mg (3.8 percent and 4.1 percent, respectively), and higher for lemborexant 10 mg (8.3 percent).

“these findings add to the growing body of clinical data supporting the development of lemborexant for the treatment of insomnia, and we look forward to presenting 12-month results from the study in a future scientific forum,” said lynn kramer, md, chief clinical officer and chief medical officer, neurology business group, eisai. “it remains our aspiration to bring a medicine to physicians and patients that helps patients sleep well at night and wake well in the morning.”

sunrise 2 is one of two phase 3 safety and efficacy studies of lemborexant conducted by eisai and purdue pharma. these studies supported the new drug application for lemborexant for the treatment of insomnia, filed with the u.s. food and drug administration, on december 27, 2018. in japan, an application is scheduled to be filed within fiscal 2018.

“the six-month findings from sunrise 2 are exciting, highlighting improvements in subjective measures of both sleep onset and sleep maintenance,” said john renger, phd, head of research & development and regulatory affairs, purdue pharma. “sunrise 2 was a robust phase 3 clinical study in which the self-reported patient outcomes are encouraging as they reflect the patients’ perception of lemborexant’s impact on enabling the patient to both fall asleep faster and stay asleep longer.”

lemborexant, which acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli, is being jointly developed by eisai and purdue pharma for the treatment of multiple sleep-wake disorders, including insomnia disorder. in addition to the treatment of insomnia disorder, a phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate alzheimer’s dementia is underway. information about ongoing clinical studies is available at clinicaltrials.gov.

eisai and purdue pharma are striving to address new unmet medical needs and to improve the lives of patients and their families.

this release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

contacts:
eisai co., ltd.                                    purdue pharma l.p.
public relations department               danielle lewis
81-(0)3-3817-5120                            1-203-588-7653

 
1. about lemborexant
lemborexant is a novel investigational small molecule compound, discovered and developed by eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). in individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. in individuals with sleep-wake disorders, it is possible that orexin signaling which regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep.

2. about sunrise 2¹
sunrise 2 was a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group study of the efficacy and safety of lemborexant in 949 male or female adult participants 18 to 88 years of age with insomnia disorder. sunrise 2 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a six-month placebo-controlled treatment period, a six-month period of active-only treatment and a two-week period without treatment prior to the end-of-study visit. in this study, during the placebo-controlled treatment period, patients were randomized to receive placebo or one of two treatment regimens (lemborexant 5 mg or 10 mg). during the active-only treatment period, patients who received placebo during the first period were re-randomized to receive lemborexant 5 mg or 10 mg. patients who received active treatment during the first period continued on the treatment to which they were originally randomized. the primary objective was to determine the efficacy of lemborexant 5 mg and 10 mg compared to placebo on patient-reported (subjective) sleep onset latency at the end of six months of treatment. key secondary endpoints were mean change from baseline in subjective sleep efficiency and subjective wake after sleep onset (swaso) for lemborexant 5 mg and 10 mg compared to placebo at the end of six months of treatment.

3. about sleep disorders
population studies show that sleep disorders affect many more people worldwide than previously thought.² insomnia disorder is the most common sleep disorder affecting approximately 30 percent of the adult population worldwide.^2,3 insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, which can lead to daytime consequences such as fatigue, difficulty concentrating and irritability.^4,5
sleeping well is essential for good health, including brain health. poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke and dementia, as well as adverse effects on mood and behavior.^4,6
experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality.⁷ studies suggest an optimal sleep duration between seven and eight hours.⁸
women are 1.4 times more likely than men to suffer from insomnia.⁹ older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking and early waking, that can lead to less sleep time.¹⁰ 

4. about eisai co., ltd
eisai co., ltd. is a leading global research and development-based pharmaceutical company headquartered in japan. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. with approximately 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including neurology and oncology.
furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.
for more information about eisai co., ltd., please visit  

5. about purdue pharma l.p.
purdue pharma l.p. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. we were founded by physicians and we are currently led by a physician. beyond our efforts to provide quality medications, purdue pharma is committed to supporting national, regional and local collaborations to drive innovations in patient care. privately held, purdue pharma is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. for more information, please visit .

references 
¹ eisai inc. a long-term multicenter, randomized, double-blind, controlled, parallel-group study of the safety and efficacy of lemborexant in subjects with insomnia disorder (e2006-g000-303). (clinicaltrials.gov identifier nct02952820). 2018. unpublished data on file.
² ferrie je, et al. sleep epidemiology – a rapidly growing field. int j epidemiol.2011;40(6):1431–1437.
³ roth t. insomnia: definition, prevalence, etiology and consequences. j clin sleep med. 2007;3(5 suppl):s7–s10.
⁴ institute of medicine. sleep disorders and sleep deprivation: an unmet public health problem. washington, dc: national academies press. 2006.
⁵ ohayon mm, et al. epidemiology of insomnia: what we know and what we still need to learn. sleep med rev. 2002;6(2):97-111.
⁶ pase mp, himali jj, grima na, et al. sleep architecture and the risk of incident dementia in the community. neurology. 2017;89(12):1244-1250.
⁷ cappuccio fp et al. sleep and cardio-metabolic disease. curr cardiol rep. 2017;19:110.
⁸ cappuccio fp et al. sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. sleep. 2010;33(5):585-592.
⁹ roth t, et al. prevalence and perceived health associated with insomnia based on dsm-iv-tr; international statistical classification of diseases and related health problems, tenth revision; and research diagnostic criteria/international classification of sleep disorders, second edition criteria: results from the america insomnia survey. biol psychiatry. 2011;69:592–600.
¹⁰ crowley, k. sleep and sleep disorders in older adults. neuropsychol rev. 2011;21(1):41-53.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been listed in the 2019 global 100 most sustainable corporations in the world (global 100), a global ranking by canada-based media and investment advisory company, corporate knights, inc. this marks eisai’s fourth inclusion on the list. ranked 73rd, eisai was the highest ranking japanese company among the eight japanese companies listed in the global 100.

the global 100 evaluates the sustainability of approximately 7,500 of the world’s major corporations based on various corporate initiatives in areas such as esg (environment, society and governance). since 2005, those companies ranking among the top 100 in the world have been announced each year at the world economic forum in davos. the global 100 is based on up to 21 key performance indicators covering financial management, clean revenue, supplier performance, employee management and resource management, with the evaluations carried out based on data publicly disclosed in financial filings, integrated reports, or through other such channels.

eisai’s corporate philosophy is to give first thought to patients and their families, and increase the benefits that health care provides as well as address diverse healthcare needs worldwide. based on this corporate philosophy, eisai is striving to sustainably enhance corporate value by strengthening its esg initiatives and increasing non-financial value.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that its in-house discovered and developed antiepileptic drug (aed) perampanel (generic name, product name: fycompa^®), for which  a new drug application (nda) was submitted for review as an adjunctive treatment for partial onset seizures in epilepsy patients 12 years of age and older in china in october 2018, has been designated for priority review by the national medical products administration (nmpa) due to perampanel’s significant clinical benefit compared to existing treatments.

the priority review and approval procedure was implemented by the nmpa in february 2016 with the aim of accelerating research, development and launch of new medicines that have significant clinical value. under the procedure the period of time until approval is expected to be shortened.

in china, it is estimated that there are approximately 9 million patients with epilepsy, with approximately 60% being affected by partial-onset seizures, and 40% of these patients with partial-onset seizures require adjunctive treatment.¹ as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds,² this is a disease with significant unmet medical need.

perampanel is a first-in-class aed discovered at eisai’s tsukuba research laboratories. administered orally once-daily, it is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes.

perampanel has been approved in over 55 countries around the world as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. in addition, perampanel has been approved in over 50 countries around the world as an adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. in the united states, perampanel is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.

eisai considers neurology including epilepsy, a therapeutic area of focus, and is striving to deliver perampanel to patients in china as soon as possible. in pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy, eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

[notes to editors]
1. about perampanel (generic name, product name: fycompa)
perampanel is a first-in-class aed discovered and developed by eisai. with epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes. perampanel is available in tablet form to be taken once daily orally at bedtime. in addition, an oral suspension formulation has been approved in the united states.

perampanel is currently approved in more than 55 countries and territories, including the united states, japan, in europe and in asia as adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. in addition, perampanel has been approved in more than 50 countries, including the united states, japan, in europe and in asia for treatment as an adjunctive therapy for primary generalized tonic clonic seizures in patients with epilepsy 12 years of age and older. in the united states, perampanel is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older.

furthermore, eisai is conducting a global phase iii clinical study (study 338) for the agent in patients with seizures associated with lennox-gastaut syndrome. in japan and europe, eisai is conducting a phase iii study in pediatric patients with epilepsy (study 311) and plans to submit a marketing authorization application in fiscal 2018. additionally, positive topline results have been obtained in a phase iii study (study 342) of perampanel as monotherapy in untreated patients with partial-onset seizures 12 years of age and older currently being conducted in japan on november 2018. based on these topline results, the company plans to submit a regulatory application in japan for perampanel as monotherapy during fiscal 2018.

2. about phase iii study (study 335) upon which the nda in china was based³

3. about epilepsy
epilepsy affects approximately 3.4 million people in the united states, 1 million people in japan, 6 million people in europe, 9 million people in china, and approximately 60 million people worldwide. as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds, this is a disease with significant unmet medical need.

epilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of epilepsy cases and generalized seizures accounting for approximately 40%. in a partial-onset seizure, an abnormal electrical disturbance occurs in a limited area of the brain, and may subsequently spread throughout the brain, becoming a generalized seizure (known as a secondarily generalized seizure). in a generalized seizure, abnormal electrical disturbances occur throughout the brain, and can be followed by a loss of consciousness or physical symptoms manifested throughout the whole body.

¹ clinical guideline 2015 in china
² “the epilepsies and seizures: hope through research. what are the epilepsies?” national institute of neurological disorders and stroke, accessed may 24, 2016, 
³ nishida t., et al. adjunctive perampanel in partial-onset seizures: asia-pacific, randomized phase iii study. acta neurol scand. 2018; 137:392-399

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the latest data on its antiepileptic drug (aed) perampanel (product name: fycompa^®) will be presented at the 72nd american epilepsy society annual meeting (aes 2018) to be held from november 30 to december 4, 2018 in new orleans in the united states.

nineteen poster presentations will be given by eisai at aes 2018, including reports on the interim analysis results of a phase iii clinical study (study 311) in pediatric patients aged 4 to less than 12 years as well as a presentation on sustained seizure-free status in the open-label extension phase of a phase iii clinical study (study 307) in patients 12 years of age and older. including investigator initiated studies, more than 50 scientific posters on perampanel will be presented at aes 2018.

perampanel is a first-in-class aed discovered at eisai’s tsukuba research laboratories. it is available in tablet form to be taken once daily, and a new oral suspension formulation has been approved and is being marketed in the united states. a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation by targeting glutamate activity at ampa receptors on postsynaptic membranes, it is approved in countries around the world as an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. furthermore, perampanel is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older in the united states.

eisai considers neurology including epilepsy, a therapeutic area of focus, and strives to deliver perampanel throughout the world in pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy. eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

major poster presentations for perampanel:

media inquiries: 
public relations department,
eisai co., ltd.
81-(0)3-3817-5120