Enlarge / The outside of the headquarters of biotechnology firm Biogen in Cambridge, Massachusetts. (credit score: Getty | Boston Globe)
Biogen’s new Alzheimer’s drug Aduhelm continues to face opposition after its contentious approval by the Meals and Drug Administration final month—which the FDA now says must be independently investigated. Some insurers say they will not pay for the drug, some hospitals say they will not administer it, and but extra consultants say it has no confirmed profit and is dramatically overpriced at $56,000 for a 12 months’s provide.
On Thursday, a panel of medical consultants convened by the nonprofit Institute for Medical and Financial Evaluation (ICER) voted 15 to zero to say that there isn’t a proof that Aduhelm offers medical profit to sufferers. The unanimous vote echoes one other one from a panel of knowledgeable advisors for the Meals and Drug Administration who voted final November towards FDA approval. Eleven of ten advisors voted that information collected in two equivalent Part III medical trials failed to indicate that the drug is efficient, with the remaining advisor voting “unsure.”
The FDA nonetheless authorised the drug on June 7, sparking a firestorm of criticism. In an unprecedented transfer final week, the FDA up to date its advice for who ought to obtain the drug, considerably narrowing the pool from all Alzheimer’s sufferers to solely these with gentle illness. It is uncommon for the FDA to make such a modification so quickly after an preliminary resolution and with out recent information to again a change.
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