GIVING IT A SHOT

FDA Approves Alzheimer’s Drug Amid Doubts Over Efficacy

The agency “will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside,” it said in a news release.

The Food and Drug Administration (FDA) on Monday approved a new Alzheimer’s medication, aducanumab, amid serious concerns from its own independent advisory committee that the drug may not actually help patients. Aducanumab, which is marketed by Biogen under the brand name Aduhelm, now becomes the first FDA-approved treatment approved for Alzheimer’s since 2003, and the first-ever meant to slow cognitive decline rather than simply treat dementia symptoms, according to a news release from the FDA.

Biogen in 2019 halted two large clinical trials of aducanumab upon realizing it wouldn’t hit its targets for efficacy. But another trial found the drug reduced declines in cognitive and functional ability by 22 percent. Although the FDA concedes that more testing is needed, the agency said the need for new Alzheimer’s therapies is doubly urgent. “FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside,” the agency’s release stated. “Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm. As an agency, we will also continue to work to foster drug development for this catastrophic disease.”