Eisai initiates rolling submission for the US FDA Biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway - Seite 2

After completion of the Core period and a Gap period off treatment (average of 24 months), all 180 patients in the Phase 2b open-label extension study received 10 mg/kg bi-weekly lecanemab dosing. The data confirmed lecanemab produces reductions of amyloid PET SUVr, with significant reduction occurring as early as 3 months, and >80% of subjects achieved amyloid negative status by visual read in as early as 12 months. Significant amyloid reduction relative to placebo in those exposed to lecanemab in the Core period was maintained while off-treatment over the Gap period. The rate of ARIA-E was consistent with the Core study at around 10%.

The lecanemab Clarity AD Phase 3 clinical trial in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The U.S. 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 BLA. 

"We are very impressed with our partner Eisai's diligent work and clinical programs to progress the development of lecanemab. Alzheimer's disease is devastating and the rolling BLA submission for lecanemab brings us one step closer to potentially being able to offer a new treatment option to millions of patients and their families," said BioArctic's CEO Gunilla Osswald.

¹ Alzheimer's Research & Therapy volume 13, Article number: 80 (2021), https://alzres.biomedcentral.com/articles/10.1186/s13195-021-00813-8 

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

For further information, please contact: 

Gunilla Osswald, CEO, BioArctic AB 
E-mail: [e-mail] 
Phone: [phone] 

Oskar Bosson, Vice President Communications and Investor Relations, BioArctic AB 
E-mail: [e-mail]
Phone: [phone] 

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, on September 28, 2021, at 1:35 a.m. CET.

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Lecanemab BLA