Biogen Inc. shares slid 4% in premarket trade Wednesday, after the company said it had received a “negative trend vote” from an advisory committee to the European Medicines Agency for its Alzheimer’s disease treatment aducanumab. The vote means that the committee was unable to agree to grant authorization to the treatment, which has already won approval from the U.S. Food and Drug Administration, in a decision deemed controversial. The Committee for Medicinal Products for Human Use is expected to adopt a formal opinion on the drug application at a meeting scheduled for Dec. 13 to 16, and Biogen said it will continue to engage with the regulator as it mulls its next steps. “While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal, M.D., M.P.H., head of global safety & regulatory sciences and interim head of R&D at Biogen. In October, a Wall Street analyst described the launch of the Alzheimer’s disease drug as“potentially the worst drug launch of all time.”
The critical note from Raymond James analyst Steven Seedhouse came in response to the news that Aduhelm, the drug’s brand name in the U.S., generated only $300,000 in sales in the third quarter of the year. It was approved by U.S. regulators back in June. Several members of the FDA’s advisory committee that voted against the agency approving Aduhelm quit in response, and acting FDA commissioner Janet Woodcock in July announced a federal investigation into the approval process for Aduhelm. Biogen shares have gained 7% in the year to date, while the SPDR S&P Biotech ETF has fallen 12% and the S&P 500 has gained 25%.
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