Biogen will stop developing its Alzheimer’s treatment, Aduhelm, a drug once considered a potential blockbuster before stumbling shortly after its launch a few years ago.
The pharmaceutical maker announced Wednesday that it would end a study of the drug needed for full approval from the Food and Drug Administration, and would halt sales of Aduhelm.
Patients taking doses of Aduhelm available on the commercial market can continue until November. A company representative said about 2,500 people worldwide take Aduhelm.
Biogen said it would focus more on other treatments for Alzheimer’s, a deadly and mind-numbing illness. The company is also helping Japanese drugmaker Eisai sell another Alzheimer’s treatment, Leqembi, which has already received full FDA approval.
Leqembi is the first drug that has been convincingly shown to slow the cognitive decline caused by Alzheimer’s disease, albeit modestly. Regulators approved it for patients with mild dementia and other symptoms caused by early Alzheimer’s disease.
Aduhelm was the first new Alzheimer’s drug introduced in almost two decades. The FDA granted accelerated approval in 2021. But regulators required additional study before considering full approval.
Initially valued at $56,000 per year, analysts predicted the drug would quickly become a blockbuster drug that would earn Biogen billions.
But doctors were hesitant to prescribe the drug intravenously, given little evidence that the drug slowed Alzheimer’s disease. Insurers blocked or restricted coverage, and the federal government’s Medicare program placed strict limits on who could get it.
This has proven particularly difficult for Biogen because most U.S. Alzheimer’s patients are old enough to qualify for the federal program, which covers patients age 65 and older.
The drug ended up generating millions, not billions, in quarterly sales for Biogen, and the company announced in 2022 that it would largely stop marketing Aduhelm.
Last year, Biogen launched an unsuccessful search for outside funding or partners to help with Aduhelm. This was done as part of a review by the company into its research and development program.
Biogen said it considered during this review the time and investment that would be required for this additional study and the likely progress in the field before Aduhelm receives full approval.