Patients and researchers often complain that the U.S. Food and Drug Administration takes too long to approve new drugs. So it might come as a surprise that a fast-tracked approval – in this case for a drug to treat Alzheimer’s disease – met pushback for being too speedy.

But that’s exactly what happened as the FDA gave a temporary green light to aducanumab following an accelerated approval process. The decision was made even though the FDA’s external advisory board urged the drug’s rejection last year because of a lack of data supporting its effectiveness. And at $56,000 a year, treatment with aducanumab will be very expensive, especially for Medicare.

To better understand the controversy surrounding the FDA’s verdict, I asked pharmacist and drug development expert C. Michael White of the University of Connecticut to break down what accelerated approval entails. He also explained the benefits for patients – and whether the drugs are worth their high cost.

Also today:

Vivian Lam

Assistant Health and Medicine Editor

Do the benefits of approving a drug before confirming it works outweigh the potential costs? monkeybusinessimages/iStock via Getty Images Plus

The FDA’s big gamble on the new Alzheimer’s drug

C. Michael White, University of Connecticut

The FDA approved Alzheimer's disease drug aducanumab despite minimal evidence of its efficacy. Whether this decision ultimately hurts or helps patients depends on data researchers don't yet have.


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