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Expected to be a big deal, Alzheimer's drug is pulled after disappointing sales

MARY LOUISE KELLY, HOST:

A drugmaker is pulling the plug on an Alzheimer's treatment that was once expected to be a blockbuster. NPR's Sydney Lupkin reports on what happened and what it could mean for patients.

SYDNEY LUPKIN, BYLINE: Aduhelm was supposed to be a big deal. That's because the drug cleared sticky clumps of protein called amyloid from the brains of patients with Alzheimer's disease. Of the two big studies of Aduhelm submitted to the Food and Drug Administration, one found that the drug delayed the loss of memory and thinking, while the other found no clear benefit. A panel of experts advising the agency recommended against approval, but the agency did it anyway in 2021 with a catch. Biogen, the drug's maker, had to do more research to confirm Aduhelm worked and get the study done by 2030. Now Biogen says it couldn't find a partner or financing to help pay for the costly confirmatory study, so it's cutting its losses and focusing on its other FDA-approved Alzheimer's drug called Leqembi. Dr. Aaron Kesselheim from Harvard was one of three FDA advisers who resigned in protest over the Aduhelm approval.

AARON KESSELHEIM: The fact that in the intervening three-plus years that there has been no additional data that's come out that suggested anything positive about this drug is an indicator to me that the advisory committee was correct in assessing this drug did not have good evidence and should not have been approved.

LUPKIN: Aduhelm never took off. Biogen initially set its price at $56,000 a year, but demand was so weak the company slashed the price in half a few months later. Medicare also limited coverage for Aduhelm to patients who were in clinical trials. Still, Biogen's decision to withdraw Aduhelm was unexpected. Heather Snyder from the Alzheimer's Association says patients were still being enrolled in the confirmatory study when Biogen made its announcement. But she says there's a silver lining.

HEATHER SNYDER: The approval of Aduhelm was a landmark event that really provided hope for so many individuals that are or were living with early Alzheimer's and their families.

LUPKIN: And other experimental Alzheimer's drugs are moving forward in the pipeline. Biogen says patients currently taking Aduhelm will have access to it until November 1, but patients taking the drug in clinical trials will lose access May 1. Biogen had licensed the drug from a Swiss biotech called Neurimmune. Neurimmune says it will continue to work on the drug and aims to seek approval for a version that is given by injection instead of infusion.

Sydney Lupkin, NPR News.

(SOUNDBITE OF MUSIC) Transcript provided by NPR, Copyright NPR.

NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

Sydney Lupkin is the pharmaceuticals correspondent for NPR.
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