Eisai and Biogen's Alzheimer’s Drug Leqembi Nears Full U.S. FDA Approval

Intelligent Finance APP learned that, according to reports, Eisai and Biogen's (BIIB.US) Alzheimer's drug Leqembi is one step closer to gaining full approval in the United States. In a briefing released on Wednesday, prior to an external advisory meeting held on Friday, the U.S. Food and Drug Administration (FDA) stated that studies have shown the drug demonstrates "consistently favorable" therapeutic effects. Risks associated with the drug "can be described in the prescribing information and do not appear to prevent the traditional approval of Leqembi."

On Friday, the FDA advisory committee will vote on whether to support the use of Leqembi for the treatment of Alzheimer's disease. The FDA does not have to follow the committee’s recommendation, but it usually does. Analysts believe that as the first drug to slow Alzheimer's disease, the drug will gain the committee’s support and FDA approval.

Wedbush analyst Laura Chico said, "We believe the most likely scenario is that Leqembi will gain committee support followed by full approval."

Medicare Confirms Coverage for Alzheimer's Drugs Like Leqembi Once Fully Approved; Potential Annual U.S. Sales Over $2 Billion: Analysts

As of the U.S. stock market close on Wednesday, Biogen Inc. rose nearly 2%. On Thursday morning, the share price of Eisai Co., Ltd. in Tokyo surged 10%, marking the largest increase in eight months and reaching its highest level since July 2021.