FDA Scientists Appear To Offer Major Approval For Controversial Biogen Treatment For Alzheimer’s Disease


STAT + subscribers will have access to all-day coverage of the Friday Advisory Board meeting to discuss the drug Biogen’s Alzheimer’s, with regular updates on key presentations, interesting arguments, and possibly the result itself. If you are a subscriber, you will be able to find this cover here. Click here to subscribe. TThe future of aducanumab, Biogen’s treatment for Alzheimer’s disease, looks brighter after reviews from the Food and Drug Administration said they believed the drug was sufficiently safe and effective.

In a lengthy document released Wednesday, FDA staff appeared to endorse approval of the treatment, which would become the first new treatment for Alzheimer’s disease in nearly two decades. The commentary, which provides the first glimpse into how FDA scientists view the often-debated treatment, comes ahead of a Friday meeting of outside advisers, who will cast a non-binding vote on whether to recommend the treatment. approval of aducanumab.


Biogen shares rose nearly 45% to $ 355, adding $ 17 billion to the company’s market value.

Biogen’s data from a large clinical trial was “robust and exceptionally convincing,” wrote the FDA reviewers, endorsing the drug’s effects on cognition in Alzheimer’s patients. A second, almost identical study did not show any significant benefit, but “upon further examination” the FDA agreed with Biogen’s argument that the sum of all data suggests aducanumab is useful for patients.



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