Biogen drops controversial Alzheimer's drug

By Eleanor Laise

Drugmaker will no longer develop or commercialize Aduhelm, focusing instead on Leqembi and potential new treatments

Biogen Inc. (BIIB) said Wednesday that it will halt the development and commercialization of its Alzheimer's drug Aduhelm, which drew intense scrutiny of its U.S. regulatory approval process due to concerns about whether its benefits outweighed its risks.

The decision to discontinue Aduhelm "is not related to any safety or efficacy concerns," Biogen said in a release, noting that it had been unable to find strategic partners or external financing for the program.

The company said it is also halting its Envision trial, a post-market confirmatory study of Aduhelm that aimed to enroll a more diverse group of patients. Lack of diversity among Alzheimer's clinical trial participants has lately been a concern for patients and drugmakers.

The decision comes as patients and investors are awaiting an FDA approval decision on Eli Lilly & Co.'s (LLY) Alzheimer's treatment donanemab, which could become a strong competitor to Leqembi.

The FDA granted Aduhelm accelerated approval in 2021 for the treatment of Alzheimer's, which affects more than 6 million people in the U.S. Aduhelm was the first new Alzheimer's treatment approved since 2003 and the first to affect the underlying disease process rather than just treating the symptoms.

But there was considerable debate about the drug's cost and effectiveness. Biogen initially set the yearly price of a maintenance dose of Aduhelm at about $56,000, but cut that price to about $28,000 at the start of 2022. The Centers for Medicare and Medicaid Services said in 2022 that Medicare would cover the drug only for people who are enrolled in clinical trials.

Biogen said Wednesday it has recorded a one-time fourth-quarter charge of about $60 million related to close-out costs for Aduhelm. The company licensed the drug from the Swiss company Neurimmune, which now regains the rights to Aduhelm, Biogen said.

Many of the resources freed up by terminating Aduhelm will be redeployed within the company's Alzheimer's business, Biogen said. The drugmaker said it will continue to advance Leqembi, the Alzheimer's treatment granted full approval last year by the U.S. Food and Drug Administration and will accelerate development of other potential new treatments.

The decision to scrap Aduhelm is "a positive," BMO Capital Markets analyst Evan David Seigerman wrote in a note Wednesday, as it allows Biogen to "focus on the more impactful Leqembi launch" and experimental drugs targeting tau, a protein that also plays a role in Alzheimer's disease.

Biogen shares were roughly flat premarket on Wednesday and are down 4.5% in the year to date, while the S&P 500 has gained 3.3%.

-Eleanor Laise

This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

01-31-24 0900ET

Copyright (c) 2024 Dow Jones & Company, Inc.