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‘Embarrassing About-Face’: FDA’s Aduhelm Labeling Change Does Little To Improve Frustration Over Alzheimer’s Approval

 
• By Sarah Karlin-Smith

US FDA’s update to Biogen’s Aduhelm label was the right move, drug policy experts say, but that doesn’t mean the agency should expect a round of applause. Instead, they expect it will only heighten the controversy and tension over the unexpected June accelerated approval of the pricey new Alzheimer’s disease drug and could further erode trust in the agency. The updated indication, which emphasizes initiating treatment in patients with mild disease, still gives plenty of wiggle room for wider prescribing.

narrow hiking path
Change to Aduhelm label may narrow patient population for Alzherimer’s treatment. • Source: Alamy

The US Food and Drug Administration modified the labeling of Biogen, Inc.’s and Eisai Co., Ltd.’s Alzheimer’s treatment Aduhelm (aducanumab-avwa) on 8 July, specifying the treatment “should be initiated” in patients with mild disease. The move was viewed as a step in the right direction by critics of the initial approval, but also brought new fears about further erosion of public trust in the regulator.

The original Aduhelm labeling did not limit use to any particular Alzheimer’s patients, even though the two Phase III clinical...

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