The European Medicines Agency has recommended the European Commission to reject Biogen Inc's (NASDAQ:BIIB) Aduhelm, an expected blow to its hopes of finding a widespread market for its struggling Alzheimer's drug.
- The EMA recommendation had been expected since the EMA's human medicines committee gave Biogen "a negative trend vote" after an oral presentation from the Company.
- Biogen said that it would appeal the decision. The EMA has 60 days after receiving the Company's re-submission to issue a final opinion.
- Related Link: Biogen Outlines Aduhelm's Confirmatory Trial Plans, Data Expected In 2026.
- The EMA noted that although Aduhelm reduces amyloid beta in the brain, the link between this effect and clinical improvement was not established.
- Results from the main studies were conflicting and did not show overall that Aduhelm effectively treated adults with early-stage Alzheimer's disease.
- In addition, the EMA took particular issue with the safety risks.
- "The studies did not show that the medicine was sufficiently safe as images from brain scans of some patients showed abnormalities suggestive of swelling or bleeding, which could potentially cause harm," they said. "Furthermore, it is not clear that the abnormalities can be properly monitored and managed in clinical practice."
- Price Action: BIIB shares are down 1.62% at $231.71 during the premarket session on the last check Friday.
