BACE Hopes Finally Fizzle As Biogen/Eisai End Elenbecestat Alzheimer's Studies
Biogen investors cheered the end of the company’s investment in the Phase III studies due to an unfavorable risk-benefit ratio – a widely expected result for the last clinical BACE inhibitor program.
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Following Biogen’s lead with Aduhelm, the first disease-modifying Alzheimer’s therapy approved in the US, Eisai began a rolling BLA submission for lecanemab (BAN2401) ahead of next year’s Phase III results.
The company remains confident in US FDA approval for the first disease-modifying Alzheimer’s drug based on current data, but Biogen needs more time to complete the BLA filing.
Biogen presented highly anticipated data in Alzheimer’s disease at CTAD for its Phase III EMERGE and ENGAGE studies, but one major question remains unanswered: will the FDA approve the drug?