Drugmaker Biogen is pulling the plug on its controversial Alzheimer’s drug Aduhelm, following disappointing gross sales. It had been anticipated to be a blockbuster product.
MARY LOUISE KELLY, HOST:
A drugmaker is pulling the plug on an Alzheimer’s therapy that was as soon as anticipated to be a blockbuster. NPR’s Sydney Lupkin stories on what occurred and what it may imply for sufferers.
SYDNEY LUPKIN, BYLINE: Aduhelm was alleged to be a giant deal. That’s as a result of the drug cleared sticky clumps of protein referred to as amyloid from the brains of sufferers with Alzheimer’s illness. Of the 2 large research of Aduhelm submitted to the Food and Drug Administration, one discovered that the drug delayed the lack of reminiscence and considering, whereas the opposite discovered no clear profit. A panel of specialists advising the company really useful towards approval, however the company did it anyway in 2021 with a catch. Biogen, the drug’s maker, needed to do extra analysis to substantiate Aduhelm labored and get the research completed by 2030. Now Biogen says it could not discover a companion or financing to assist pay for the expensive confirmatory research, so it is slicing its losses and specializing in its different FDA-approved Alzheimer’s drug referred to as Leqembi. Dr. Aaron Kesselheim from Harvard was one among three FDA advisers who resigned in protest over the Aduhelm approval.
AARON KESSELHEIM: The incontrovertible fact that within the intervening three-plus years that there was no further knowledge that is come out that recommended something constructive about this drug is an indicator to me that the advisory committee was right in assessing this drug didn’t have good proof and shouldn’t have been authorized.
LUPKIN: Aduhelm by no means took off. Biogen initially set its value at $56,000 a 12 months, however demand was so weak the corporate slashed the worth in half a couple of months later. Medicare additionally restricted protection for Aduhelm to sufferers who have been in medical trials. Still, Biogen’s choice to withdraw Aduhelm was surprising. Heather Snyder from the Alzheimer’s Association says sufferers have been nonetheless being enrolled within the confirmatory research when Biogen made its announcement. But she says there is a silver lining.
HEATHER SNYDER: The approval of Aduhelm was a landmark occasion that basically supplied hope for thus many people which are or have been dwelling with early Alzheimer’s and their households.
LUPKIN: And different experimental Alzheimer’s medication are shifting ahead within the pipeline. Biogen says sufferers at the moment taking Aduhelm can have entry to it till November 1, however sufferers taking the drug in medical trials will lose entry May 1. Biogen had licensed the drug from a Swiss biotech referred to as Neurimmune. Neurimmune says it’ll proceed to work on the drug and goals to hunt approval for a model that’s given by injection as an alternative of infusion.
Sydney Lupkin, NPR News.
(SOUNDBITE OF MUSIC)
Copyright © 2024 NPR. All rights reserved. Visit our web site phrases of use and permissions pages at www.npr.org for additional data.
NPR transcripts are created on a rush deadline by an NPR contractor. This textual content might not be in its remaining kind and could also be up to date or revised sooner or later. Accuracy and availability could differ. The authoritative report of NPR’s programming is the audio report.