Biogen and Eisai Submit Marketing Authorization Application for Leqembi (lecanemab) in the European Union for Early Alzheimer's Disease

According to the Zhitong Finance APP, Biogen (BIIB.US) and its Japanese partnerEisai (ESALY.US)Marketing Authorization Application for Leqembi (lecanemab), a Breakthrough Alzheimer's Disease Treatment, Submitted in the EU.

The application to the European Medicines Agency (EMA) is based on the results of the Phase 3 Clarity study and the Phase 2b clinical study, which indicate that lecanemab treatment can reduce clinical decline in early Alzheimer's disease.

EisaiThe European Commission is expected to make a decision on lecanemab's MAA in the first quarter of the 2024 fiscal year (ending June 30, 2024).

Earlier this week, Leqembi, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, was approved in China for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease.

In July 2023, the U.S. FDA fully approved Leqembi for adult Alzheimer's disease, and subsequently, the two companies launched the product in the United States at a price of $265,000. The drug was later introduced in Japan, with an annual cost per patient of approximately 2.98 million yen (equivalent to $204,000).

Eisai Co., Ltd. is leading the global development and regulatory submissions for lecanemab, and EisaiBiogenJoint commercialization and co-promotion of the product, with Eisai having the final decision-making authority.

Swedish research-based biopharmaceutical company BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordic region with Eisai.

Combined with today's announcement of the regulatory submission to the EMA and the EMA’s subsequent acceptance of the filing, BioArctic is eligible to receive a MEUR 5 milestone.