Drugmaker Biogen will discontinue development and marketing for Aduhelm, a landmark Alzheimer's disease treatment that also provoked controversy over conflicting data around its efficacy, the company said Wednesday.
The FDA granted accelerated approval to the drug, which target amyloid plaques in the brain that are thought to contribute to the disease, in 2021. That endorsement was contingent upon Biogen completing a follow-up study confirming that the treatment's benefits outweigh the risks.
But after an internal review of its research and development efforts, the company determined that it should redirect its resources toward developing other drug candidates and advancing Leqembi, another Alzheimer's drug it's marketing with Eisai that won traditional FDA approval last year.
“When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed," Christopher A. Viehbacher, Biogen's president and CEO, said in a statement. "ADUHELM was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”
While Aduhelm and Leqembi were applauded as breakthroughs in Alzheimer's care, their clinical trials showed modest benefits for patients — along with potentially dangerous side effects like brain bleeding and swelling.
Medicare has limited coverage of Alzheimer's drugs with accelerated approval to only patients participating in a randomized clinical trial, of which none were enrolling.
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