A House investigation released last week unearthed a trove of documents that shed new light on the polarizing approval and disastrous rollout of Aduhelm, the first new drug for Alzheimer’s disease in two decades. But crucial questions remain for the Food and Drug Administration, Biogen, and the future of treating Alzheimer’s disease.
The FDA has not made clear just what it has changed since the Aduhelm debacle, and the revelations about its inner workings — and the blow to its credibility — came just days before the agency is expected to approve another medicine for Alzheimer’s.
Biogen, which has gone through upheavals of its own, faces the task of rebuilding its business and reputation alike. And the entire Alzheimer’s community has turned its attention to new treatments on the horizon that must go through the same FDA process that brought Aduhelm to market. If they’re approved, will their makers face headwinds trying to win over a more-skeptical medical community, patients, and Medicare, which refused to broadly cover Aduhelm?
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