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Eisai Anticipates EU Decision on BioArctic's Lecanemab in Q2

• Eisai anticipates a decision from the European Medicines Agency (EMA) regarding marketing authorization for lecanemab in the second quarter of this year. • The EMA's Scientific Advisory Board is scheduled to convene in the first quarter to discuss the marketing authorization application for lecanemab. • BioArctic and Eisai are jointly preparing for the commercialization of lecanemab in Nordic countries, pending European approval. • Eisai collaborates with Biogen globally on the marketing and commercialization of lecanemab, sharing costs and potential profits equally.

Eisai, partner of BioArctic, announced that the European Medicines Agency's (EMA) Scientific Advisory Board will meet to discuss the marketing authorization application for lecanemab (Leqembi). The advisory group meeting is expected to take place in the first quarter of this year.
Eisai anticipates a decision on marketing authorization in the second quarter of this year, contingent on receiving an opinion from the Committee for Medicinal Products for Human Use (CHMP) by March 31, following the Advisory Group discussion. BioArctic has licensed lecanemab to Eisai in exchange for milestone payments and royalties on sales.
Currently, BioArctic and Eisai are preparing for joint commercialization in the Nordic countries, pending European approval. Globally, Eisai collaborates with Biogen on the marketing and commercialization of lecanemab, sharing costs and potential profits equally. Lecanemab represents a significant advancement in Alzheimer's treatment, targeting amyloid plaques in the brain, a key pathological hallmark of the disease.
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Reference News

[1]
Eisai expects EU decision on Bioarctic's lecanemab in Q2 - MarketScreener
marketscreener.com · Oct 23, 2024

Eisai anticipates a Q2 EU decision on Bioarctic's lecanemab, with the EMA's Scientific Advisory Board meeting in Q1 to d...

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