Eisai, Biogen Initiate Rolling Submission For New Alzheimer's Drug

Eisai Co Ltd 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 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.