Biogen walks away from controversial Alzheimer’s drug Aduhelm

Pharmaceutical company Biogen announced Wednesday that it will relinquish ownership of its Alzheimer’s disease drug Aduhhelm, which sparked intense criticism of the company and the Food and Drug Administration (FDA) after it was approved in 2021.

The company will also halt ongoing post-approval clinical trials ordered by the FDA to determine the drug’s effectiveness in patients with early-stage Alzheimer’s disease.

“In the search for new drugs, one breakthrough discovery can be the foundation that sparks future drug development,” Biogen CEO Christopher Wiebacher said in a statement. Ta. “Aduhelm was a breakthrough discovery that paves the way for a new class of medicines and reinvigorates investment in this field.”

Biogen said it would prioritize Rekenbi, another Alzheimer’s disease drug based on the same science as Aduhhelm, which the company developed with Japanese manufacturer Eisai. The drug company said it also plans to accelerate development of other potential Alzheimer’s disease treatments.

Biogen will return the rights to Aduhhelm to Swiss-based biotechnology company Neurimmune.

Last year, Rekenbi received FDA approval as the first drug that can slow the gradual cognitive decline caused by Alzheimer’s disease.

Biogen’s decision to withdraw from Aduhhelm ended plans for a drug that was once predicted to be a blockbuster, but ended up at the center of controversy and undermined confidence in the FDA’s approval process. The company has become a poster child for the profit maximization mentioned above. Everything else.

The agency granted early approval to Adherm in 2021, overruling an external advisory panel that recommended against it. Three members of the advisory committee resigned in protest, with one calling the FDA’s action “probably the worst drug approval decision in recent U.S. history.”

It is the first new Alzheimer’s disease drug approved in nearly 20 years, and was brought to market at a price of $56,000. But the evidence that the drug works was sparse at best.

House Democrats launched an investigation that ultimately found the confirmation process to be “unusual” and “riddled with fraud.” FDA and Biogen improperly cooperated and did not follow the agency’s process for documenting meetings.

A Congressional investigation found that Biogen recognized its $56,000 launch price was “unreasonably high,” but company executives said they would “make history” and “promote Aduhhelm as one of the top drug launches in history.” It was also revealed that he wanted to establish it as one of the leading companies in Japan. The company estimates potential peak revenue at $18 billion annually.

But after doctors worried about serious side effects, including bleeding in the brain, Medicare drastically reduced coverage of the drug, making it available only to patients in clinical trials.

Through 2022, Aduhelm’s sales will be just $4.8 million, and the company announced it will largely cease marketing.

Biogen recorded a one-time charge of approximately $60 million related to program exit costs.