FDA faces blowback over Alzheimer's drug approval

The U.S. Food and Drug Administration's decision this week to approve the first new Alzheimer's drug in nearly 20 years is facing mounting criticism - even from its own advisors.

Three resigned in protest after Biogen’s treatment Aduhelm was granted (quote) “accelerated approval."

Regulatory and scientific experts say the FDA is taking its biggest risk yet with this strategy, which allows new therapies onto the market without strong evidence they work.

The FDA has granted "accelerated approval" in more than 250 instances since 1992, but mainly for rare diseases or small patient populations that have had no effective treatments available to them.

Aduhelm, however, is in a different league - both in terms of its potentially large patient pool and its hefty cost to the healthcare system - with each treatment costing $56,000 a year.

In addition, the FDA ignored the recommendation of outside advisors, who said Biogen did not provide enough evidence of the drug’s clinical benefit – prompting the resignations.

The FDA has defended its decision by saying Biogen presented clear evidence that Aduhelm removed amyloid plaques from the brains of people with Alzheimer's.

Aduhelm must still go through a post-approval trial, after which the FDA can pull the drug from the market if it doesn’t meet required standards.

But Biogen has said that trial could take nine years to complete.

Patient advocate groups, like UsAgainstAlzheimer’s, have hailed the FDA’s decision, but critics - like Dr. Jason Karlawish, who ran one of the trial sites for Aduhelm – are concerned.

Karlawish called the FDA’s decision (quote), “a disturbing set of events, scientifically, clinically, politically."