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The European Union's drug regulator has delayed its decision on Eisai (OTCPK:ESALF) (OTCPK:ESAIY) and partner Biogen's (NASDAQ:BIIB) breakthrough Alzheimer's therapy, Leqembi (lecanemab).
Lecanemab, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, has been under review in Europe since last year.
Earlier this week, the European Medicines Agency (EMA) had said it would hold an oral hearing on lecanemab on March 19, but the scheduled meeting "did not take place due to procedural reasons at EMA" according to Eisai.
Eisai noted: "The decision is entirely related to procedural reasons at EMA and is not related to the Marketing Authorisation Application for lecanemab itself." It will continue to collaborate with EMA during the review.
Lecanemab has been approved in China, Japan and the U.S. as a treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease. Eisai and Biogen hold rights to co-commercialize the drug.
Eisai (OTCPK:ESAIY) ADRs are currently down -2.24% premarket on Friday.