Eisai, Biogen Initiate Rolling Submission For New Alzheimer's Drug
- Eisai Co Ltd (OTC: ESALY) began its application process for lecanemab (BAN2401) for early Alzheimer's disease using an accelerated approval pathway.
- Lecanemab is an anti-amyloid beta (Aβ) protofibril antibody.
- In March 2014, Eisai and Biogen Inc (NASDAQ: BIIB) entered into a joint development and commercialization agreement for lecanemab, and the parties amended that agreement in October 2017.
- Biogen / Eisai drug Aduhelm was the first Alzheimer's treatment to win approval in nearly 20 years, but the FDA's controversial use of the accelerated approval process has come under heavy fire.
- Read Next: Aduhelm's 'Blockbuster Potential' Is Underappreciated, Says Biogen Analyst
- Eisai will submit its application to the FDA on a rolling basis to complete it in the next few months.
- The Company plans to submit data from its midstage trial of 856 volunteers, which showed that 80% of patients had no amyloid left in their brains after 18 months of treatment.
- The lecanemab Clarity AD Phase 3 trial in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients.
- The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.
- Blinded safety data from Clarity AD will be included to support the marketing application.
- Also Read: Congress Asks For Approval Documents Of Biogen's Alzheimer's Drug.
- Price Action: BIIB shares traded 0.83% higher at $289 premarket on the last check Tuesday.
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