|
| Friday, 18 November 2016, 09:28 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
TOKYO, Nov 18, 2016 - (JCN Newswire) - Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of the beta secretase cleaving enzyme (BACE) inhibitor E2609 which was discovered by Eisai and is being jointly developed by Eisai and Biogen Inc. E2609 is currently being investigated in Phase III clinical studies for early Alzheimer's disease.
Fast Track is a process designed to facilitate the development and review of drugs to treat serious conditions and tackle key unmet medical needs by allowing for frequent interactions with the FDA. It may also enable Priority Review by the FDA if supported by clinical data at the time of New Drug Application submission.
Discovered in-house by Eisai, E2609 is an investigational next-generation oral candidate for the treatment of Alzheimer's disease that is believed to inhibit BACE, a key enzyme in the production of amyloid beta (Abeta). By inhibiting BACE, E2609 may decrease the formation of toxic Abeta peptide aggregates and amyloid plaques in the brain, thereby potentially slowing disease progression. The first Phase III study for E2609 in the clinical trial program called MISSION AD began in October 2016 and will enroll 1,330 patients with biomarkers confirmed for early Alzheimer's disease.
"We are excited that the FDA has granted Fast Track designation to E2609" said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer of the Eisai Neurology Business Group. "We look forward to working closely with the FDA to expedite this clinical program and hope to offer an important treatment option for patients who suffer from early Alzheimer's disease as soon as possible."
About the U.S. Food and Drug Administration's Fast Track Designation
Fast Track is a special measure provided by the U.S. Food and Drug Administration (FDA) to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The Fast Track designation is available not only when treatments do not exist, but also for drugs that demonstrate a potential advantage over existing treatments. Once a drug has granted Fast Track designation, the FDA will increase the frequency of meetings to discuss development, and if supported by clinical data at the time of New Drug Application submission, the drug may also be eligible for Accelerated Approval and Priority Review.
About the Clinical Trial Program for E2609 (MISSION AD)
The clinical trial program for E2609 (MISSION AD) consists of two global Phase III studies, MISSION AD1 (Study 301) and MISSION AD2 (Study 302). The first study of the MISSION AD program, MISSION AD1, is a multicenter, placebo-controlled, double-blind, parallel-group clinical study aiming to assess the efficacy and safety of E2609 in 1,330 patients with biomarker confirmed early Alzheimer's disease. Patients will be randomized 1:1 to receive either a dosage of 50 mg of E2609 or placebo daily during the treatment period of 24 months, and the primary endpoint will utilize the Clinical Dementia Rating Sum of Boxes (CDR-SB).
About the Joint Development Agreement between Eisai and Biogen
Based on this agreement, Eisai and Biogen will co-develop Eisai's investigational next generation AD treatment candidates E2609, a BACE inhibitor, and BAN2401, an anti-amyloid beta (Abeta) protofibril antibody, in major markets, such as the United States, the European Union and Japan. If approved, the companies will also co-promote the products. Both companies will share overall costs, including research and development expenses. Eisai will book all sales for E2609 and BAN2401 following marketing approval and launch, and profits will be shared between the companies. Also, Eisai has received from Biogen an additional one-time payment as well as the right to receive additional development milestone payments. Under the same agreement, Eisai also holds options to jointly develop and commercialize two of Biogen's candidates for Alzheimer's disease, the anti-Abeta antibody aducanumab and an anti-tau antibody.
Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
Topic: Press release summary
Source: Eisai
Sectors: Healthcare & Pharm
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| Apr 1, 2025 12:15 HKT/SGT |
|
Eisai to Divest Rights for Pariet in China to Peak Pharma |
| Mar 25, 2025 16:28 HKT/SGT |
|
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards |
| Mar 25, 2025 11:21 HKT/SGT |
|
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace |
| Mar 10, 2025 19:24 HKT/SGT |
|
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time |
| Mar 5, 2025 08:09 HKT/SGT |
|
Eisai: Update on the Co-Promotion of the Oral Antifungal Agent Nailin Capsules 100mg in Japan |
| Mar 4, 2025 16:22 HKT/SGT |
|
Eisai Receives Regulatory Review Outcome for Lecanemab as a Treatment for Early Alzheimer's Disease in Australia |
| Mar 3, 2025 14:41 HKT/SGT |
|
"Fatigue Recovery While You Sleep!" Eisai to Launch Designated Quasi-Drug Drink "Chocola BB Nightwell" |
| Mar 3, 2025 12:53 HKT/SGT |
|
The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease |
| Feb 28, 2025 11:31 HKT/SGT |
|
Eisai Enters into License Agreement for the Development and Distribution of Fibroblast Growth Factor (FGF) Receptor Selective Tyrosine Kinase Inhibitor Tasurgratinib in Greater China Region (Mainland China, Hong Kong, Macau, and Taiwan) with SciClone |
| Feb 20, 2025 12:29 HKT/SGT |
|
Eisai Selected for "Human Capital Leaders 2024" and "Human Capital Management Gold Quality" for Second Consecutive Year, as a Company Committed to Excellent Management and Disclosure of Human Capital Initiatives |
| More news >> |
 |
|
|
|
