F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

Pam Belluck and Rebecca Robbins

The Food and Drug Administration on Monday approved the first new medication for Alzheimer’s disease in nearly two decades, a contentious decision, made despite opposition from the agency’s independent advisory committee and some Alzheimer’s experts who said there was not enough evidence that the drug can help patients.

The drug, aducanumab, which will go by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimer’s instead of just addressing dementia symptoms.

Recognizing that clinical trials of the drug had provided incomplete evidence to demonstrate effectiveness, the F.D.A. granted approval on the condition that the manufacturer, Biogen, conduct a new clinical trial.

During the several years it could take for that trial to be concluded, the drug will be available to patients, the agency said. If the post-market study, called a Phase 4 trial, fails to show the drug is effective, the F.D.A. can — but is not required to — rescind its approval.

Click here to read more of this New York Times article by Pam Belluck and

 

Get RTP content in your inbox!

Sign up now to stay up-to-date on all RTP content and events.

  • This field is for validation purposes and should be left unchanged.