Benzinga | Sep 28, 2021 09:19AM EDT

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 (A?) 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.