May 14, 2024 | Business
Eisai Co., Ltd. announced today that it has received approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa® (generic name: perampanel hydrate) for adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.
Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes.
In China, Fycompa was approved for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy aged 12 years and older in September 2019.
Since its launch in January 2020, it has received approval in July 2021 for the additional indications for monotherapy and adjunctive use in the treatment of partial-onset seizures in patients with epilepsy aged 4 years and older, thereby expanding its contribution to epilepsy patients in China.
In China, it is estimated that there are approximately 9 million patients with epilepsy.(1) As 30%-40% of patients with epilepsy are unable to control their seizures with currently available AEDs.(2) As one of the most severe forms of epileptic seizures, primary generalized tonic-clonic seizures can cause significant injury to patients and are one of the leading risk factors associated with sudden unexpected death in epilepsy (SUDEP). Through this indication expansion, Fycompa can now be used in China as an adjunctive treatment for primary generalized tonic-clonic seizures.
Eisai considers neurology, including epilepsy, a therapeutic area of focus. As a human health care company, Eisai pursues its mission to provide “seizure freedom” to a greater number of patients with epilepsy. Eisai remains committed to further addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.
About Fycompa (generic name: perampanel hydrate)
Fycompa is a first-in-class anti-epileptic agent (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. Fycompa is currently approved in more than 75 countries and territories, including Japan, China, and other countries in Europe and in Asia 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, Fycompa has been approved in more than 75 countries, including Japan, China, 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 Japan and China, Fycompa is approved 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 Europe, the approved age range is 4 years of age and older for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) and 7 years of age and older for the treatment as an adjunctive therapy for primary generalized tonic-clonic seizure. A tablet, fine granule formulation and injection formulation have been approved in Japan. An oral suspension formulation and tablet have been approved in Europe and China. In January 2023, the commercial rights in the United States were transferred to Catalyst Pharmaceuticals, Inc.
About Epilepsy
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.
Epilepsy affects approximately 50 million people worldwide.(3) As 30-40% of patients with epilepsy are unable to control their seizures with currently available AEDs,2 this is a disease with significant unmet medical needs. Although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly. As causes and clinical symptoms of pediatric epilepsy are not uniform, and prognoses can range from very positive cases to obstinate cases, special consideration for each patient is required of treatments.
(1) Jianming Liu et.al, Treatment of epilepsy in China: Formal or informal. Neural Regen Res. 2013; 8(35): 3316–3324. www.ncbi.nlm.nih.gov/pmc/articles/PMC4145945/pdf/NRR-8-3316.pdf
(2) Jong Woo Lee and Barbara Dworetzky; Rational Polytherapy with Antiepileptic Drugs. Pharmaceuticals 2010; 3(8): page 2362–2379.doi: 10.3390/ph3082362 www.ncbi.nlm.nih.gov/pmc/articles/PMC4033928/pdf/pharmaceuticals-03-02362.pdf
(3) World Health Organization Fact Sheets; Epilepsy
www.who.int/news-room/fact-sheets/detail/epilepsy
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Apr 18, 2024 | Business
Eisai Co., Ltd. announced today that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan. The injection formulation of Fycompa received manufacturing and marketing approval on January 18, 2024 and was included in the Japan’s National Health Insurance (NHI) Drug Price List today.
Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Two oral formulations of Fycompa are available in Japan: a tablet and a fine granule formulation. Due to concern about the risks of seizures associated with interruption of administration when the drug cannot be taken orally temporarily, such as during surgery, it is suggested that epilepsy patients should continue treatment via routes other than oral administration.
Since Fycompa is the only AMPA receptor antagonist-based AED, Eisai developed this injection formulation to meet the needs of patients who are unable to use oral administration, and leading to the launch today.
Eisai considers neurology, including epilepsy, a therapeutic area of focus. As a human health care company, Eisai pursues its mission to provide “seizure freedom” to a greater number of patients with epilepsy. Eisai remains committed to further addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.
For more information, visit www.eisai.com/news/2024/pdf/enews202426pdf.pdf.
Media Inquiries:
Public Relations Department
Eisai Co., Ltd.
+81-(0)3-3817-5120
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Dec 1, 2023 | Business
Eisai Co., Ltd. announced today that its Thai sales subsidiary Eisai (Thailand) Marketing Co., Ltd., (Eisai Thailand) has made an agreement to collaborate with the Department of Medical Services (DMS), Ministry of Public Health (MOPH) of Thailand to further enhance the access to treatments for dementia including Alzheimer’s disease (AD) in Thailand.
In Thailand, the number of people suffering from dementia is expected to increase significantly from the current 700 thousand to 2 million by 2050 due to the rapid aging of the population.*1 Dementia and AD are the third leading cause of death among women (7.1% of total deaths) and the ninth leading cause of death for men (3.3% of total deaths),*2 making the need to build a system to counter dementia urgent.
With this agreement, Eisai Thailand and DMS have identified three key challenges to addressing issues regarding dementia and AD in Thailand: (1) raising disease awareness for Mild Cognitive Impairment (MCI) and dementia including AD (2) improving diagnosis infrastructure for MCI and dementia including AD and ensuring civilian access to these services (3) ensuring total care by building a dementia community and ecosystem for people with dementia and their families.
Formulation of disease guidelines by the state is essential to address these challenges. Eisai Thailand and DMS will jointly conduct surveys and other initiatives to establish such guidelines. Additionally, both organizations will promote implementation of these guidelines in collaboration with various stakeholders, including those from different industries, to develop an ecosystem dedicated to dementia, seeking to establish a strong support system for the dementia community in Thailand.
Eisai will continue to support people with dementia and their families to “live their fullest lives” to effectively achieve social good in the form of “relieving anxiety over health” and “reducing health disparities”.
(1) Alzheimer’s Disease International. & Alzheimer’s Australia. (2014). Dementia in the Asia Pacific Region. London: Alzheimer’s Disease International.
(2) Burden of Disease Thailand Report 2019
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
Copyright ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
May 27, 2023 | Business
Eisai Co., Ltd. has announced that it will grant a total of 625 million yen to the Global Health Innovative Technology Fund (“GHIT Fund”) to fund the third phase of its activities, which will take place in the five-year period from FY2023 to FY2027. The GHIT Fund is a public-private partnership, co-established in April 2013 by partners such as Japanese pharmaceutical companies (including Eisai), the Japanese government, and the Bill & Melinda Gates Foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in Japan and overseas. Eisai has provided a total of 1 billion yen to the first phase (FY2013 – FY2017) and the second phase (FY2018 – FY2022) of the GHIT Fund.
In order to develop treatments for the numerous people suffering from infectious diseases such as neglected tropical diseases (NTDs) and malaria in developing and emerging countries, there are disease-specific development and marketability issues to overcome. It is also necessary to establish local supply systems and help patients secure access to diagnosis and treatments. The key to overcoming these challenges are industry-government-academia partnerships which transcend the usual sector boundaries.
Eisai considers making efforts to resolve the global issue of access to medicines to be its duty. Under a public-private partnership including governments, international organizations, and private non-profit organizations, Eisai has participated in 23 joint research projects to develop new medicines and vaccines for mycetoma, malaria and filariasis, with the support of the GHIT Fund.
Eisai has conducted a Phase II clinical trial of its in-house developed agent E1224 (generic name: fosravuconazole) in Sudan for the treatment of mycetoma in partnership with the non-profit organization Drugs for Neglected Diseases initiative (DNDi). Eisai is also conducting a Phase II clinical trial of antimalarial agent SJ733 in collaboration with the University of Kentucky.
Eisai considers efforts for improving access to medicines, such as the elimination of NTDs and malaria, as activities aimed at creating long-term corporate value and social impact based on its corporate concept of human health care (hhc). We will continue to strengthen cooperation with our global partners and contribute to “relieving anxiety over health” and “reducing health disparities” for people at risk of infection with NTDs and those suffering from theses diseases.
About the Global Health Innovative Technology Fund (GHIT Fund)
The GHIT Fund is a Japan-based international public-private partnership fund (PPP) that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world’s vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. www.ghitfund.org/en(New Window)
About Neglected Tropical Diseases (NTDs)
Neglected Tropic Diseases (NTDs) include 20 diseases that the World Health Organization (WHO) identifies as tropical diseases which human race must overcome. More than 1.7 billion people living in the poorest and most marginalized communities worldwide are exposed to the risk of NTD infection. The spread of NTDs is mainly caused by poor hygienic conditions associated with poverty. Infections from these diseases may result in serious physical impairment and this often results in normal economic and social activities becoming highly challenging to the individual. In the worst cases, NTDs may also result in death. The prevalence of NTDs is a stumbling block to economic growth for developing and emerging countries.
The following 20 NTDs have been designated by the WHO for control or elimination: dengue fever and chikungunya, rabies, trachoma, buruli ulcer, endemic treponematoses (yaws), leprosy (Hansen’s disease), Chagas disease, African sleeping sickness (Human African trypanosomiasis), leishmaniasis, taeniasis/cysticercosis, dracunculiasis (guinea worm disease], echinococcosis, food-borne trematode infections, lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminthiasis, mycetoma, scabies and snakebite envenoming.
About Mycetoma
Mycetoma was officially recognized as the 18th NTD by the WHO in 2016. It is considered to be one of the most neglected tropical diseases since there is a lack of basic information including its transmission pathway and incidence. Mycetoma is a progressive, chronic subcutaneous infectious disease. While most commonly seen in the feet, it can also occur in other parts of the body. It is caused by bacteria or fungus entering the body through a cut or wound and infecting the tissue beneath the skin.(1)
Mycetoma is divided into two subtypes: Actinomycetoma (caused by bacterial infection) and Eumycetoma (caused by fungal infection). Actinomycetoma can be treated with antibiotics, with more than 90% success rate. On the other hand, while azole anti-fungal drugs can be used to treat Eumycetoma, the effectiveness is limited often resulting in recurrence and surgery or amputation of limbs.
About Malaria
Malaria, one of the three major infectious diseases, is caused by malaria parasites that are transmitted to people through the bite of an infected mosquito. According to the WHO, about the half of the world’s population is exposed to the risk of malaria, and there were an estimated 247 million malaria cases in 85 countries in 2021, of which about 620,000 lost their life. In particular, infants, children under the age of five, and pregnant women are more likely to develop serious illness and are always at risk of life-threatening conditions.(2)
Recently, strains of malaria which are resistant to existing medicines have been reported, and the development of a new medicine with a novel mechanism of action is an urgent priority. The majority of available antimalarial medicines target the blood-stage, in which the parasites replicate within erythrocytes, but medicines for the liver and transmission stages are limited. In order to completely cure malaria, prevent relapse, and prevent malaria being spread via mosquitoes, it is necessary to develop a new antimalarial medicine which targets all stages of the parasite lifecycle.
(1) WHO Mycetoma www.who.int/buruli/mycetoma/en/
(2) WHO Malaria www.who.int/news-room/fact-sheets/detail/malaria
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
Mar 6, 2023 | Business
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBITM (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ), approved under the Accelerated Approval Pathway for the treatment of Alzheimer’s Disease (AD) on January 6, 2023.
On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
The sBLA is based on the findings from Eisai’s recently published large, global confirmatory Phase 3 clinical trial, Clarity AD. LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.
LEQEMBI was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI’s clinical benefit in a confirmatory trial. The FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
Treatment with LEQEMBI should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.
* Protofibrils are large Aβ aggregated soluble species of 75-500 Kd.1 To learn more, visit www.LEQEMBI.com.
For more information, visit www.eisai.com/news/2023/pdf/enews202316pdf.pdf.
Copyright ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
