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FDA adviser resigns over approval of new Alzheimer's drug

June 10, 2021. Summarized by summa-bot.

Compression ratio: 27.2%. 1 min read.

A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts, U.S., on Monday, June 7, 2021. Biogen Inc. shares soared after its controversial Alzheimer's disease therapy was approved by U.S. regulators, a landmark decision that stands to dramatically change treatment for the debilitating brain condition. Photographer: Adam Glanzman/Bloomberg

A member of an FDA advisory committee said Wednesday he had resigned over the agency's approval of a new Alzheimer's drug.

(CNN)A member of a US Food and Drug Administration advisory committee said Wednesday he had resigned over the agency's approval of a new Alzheimer's drug.

The FDA approved aducanumab, to be sold under the brand name Aduhelm, this week over the objections of its advisory Peripheral and Central Nervous System Drugs Advisory Committee.

The FDA's advisers said there wasn't enough evidence to support approving the drug, which is given by infusion.

But the drug's maker, Biogen, re-analyzed data and said there was an indication it might help some patients.

Advocates for approval said the need is desperate, while opponents say the drug -- priced at $56,000 a year -- would bring in billions for Biogen while failing to help patients.

But the FDA decided the evidence showed the drug, given as an infusion, could reduce levels of amyloid in the brain and said this might help some patients.

by summa-bot

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