Biogen Inc (NASDAQ:BIIB) shares rose in pre-market trading on Monday after a Food and Drug Administration (FDA) panel voted in favor of Eisai and Biogen’s drug LEQEMBI as a treatment for Alzheimer’s disease, clearing the way for traditional approval of the drug.
The FDA Peripheral and Central Nervous System Drugs Advisory Committee said on Friday that data from a global Phase 3 trial in Alzheimer’s patients confirmed the clinical benefit of LEQEMBI in the disease, according to a statement from Biogen.
Traditional approval of LEQEMBI is expected on July 6, 2023, the company reported.
The news has eased concerns that traditional approval of the treatment would come with major new safety warnings, for example, around the side effects of LEQEMBI in patients also taking drugs that prevent blood clots, per a Reuters report.
Biogen shares had added 2.6% at US$317 before the opening bell Monday.
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