Drugmaker Biogen said Wednesday it will give up its ownership of Aduhelm, the Alzheimer’s treatment drug that sparked intense criticism of the company and the Food and Drug Administration (FDA) after it was approved in 2021.
The company will also terminate an ongoing post-approval clinical trial that FDA ordered to confirm the drug’s benefits in people with early-stage Alzheimer’s disease.
“When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed,” Biogen CEO Christopher Viehbacher 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.”
Biogen said it will prioritize Leqembi, another Alzheimer’s drug based on the same science as Aduhelm that the company developed with Japanese manufacturer Eisai. The drugmaker said it also plans to accelerate the development of other potential Alzheimer’s treatments.
Biogen will return the rights to Aduhelm to Neurimmune, a Switzerland-based biotech company.
Leqembi gained FDA approval last year as the first drug that can slow the cognitive decline from Alzheimer’s disease, though only moderately.
Biogen’s decision to move on from Aduhelm closes the book on what was once projected to be a major blockbuster drug, but ended up the center of a controversy that eroded trust in FDA’s approval process and made the company a poster child of profit maximization above all else.
The agency granted accelerated approval to Aduhelm in 2021, overruling an outside advisory panel that recommended against it. Three members of the advisory panel resigned in protest, with one calling FDA’s actions “probably the worst drug approval decision in recent U.S. history.”
It was the first new Alzheimer’s drug approved in nearly 20 years, and hit the market with a price tag of $56,000. But the evidence that the drug worked was scant, at best.
House Democrats launched an investigation, and eventually found the approval process was “atypical” and “rife with irregularities.” FDA and Biogen inappropriately collaborated and failed to follow the agency’s process for documenting the meetings.
The congressional investigation also showed that Biogen knew its $56,000 launch price was “unjustifiably high,” but company executives wanted to “make history” and “establish Aduhelm as one of the top pharmaceutical launches of all time.” The company estimated a potential peak revenue of $18 billion per year.
But amid concerns from doctors about serious side effects including brain bleeding, Medicare sharply reduced coverage of the drug, making it available only to patients in clinical trials.
Over the course of 2022, Aduhelm managed just $4.8 million in sales, and the company said it would largely cease marketing it.
Biogen recorded a one-time charge of approximately $60 million related to close out costs for the program
