Biogen is discontinuing its controversial Alzheimer's drug Aduhelm
The drug manufacturer Biogen said on Wednesday it would give up its ownership rights to Aduhelm, an Alzheimer's drug that had drawn fierce criticism from the company and regulators after it was approved based on weak evidence that it would help patients.
The company will also halt a clinical trial that the Food and Drug Administration ordered to confirm whether the drug is effective in slowing the progression of Alzheimer's disease.
With an initial sticker price of $56,000 per year, Aduhelm was once expected to be taken by millions of Alzheimer's patients, putting pressure on the Medicare budget and generating billions of dollars per year. But Aduhelm failed spectacularly in the marketplace.
Biogen's decision concludes a years-long saga that sparked outrage and undermined confidence in the regulatory process for bringing new drugs to market. One FDA adviser called the drug's approval perhaps “the worst approval decision the FDA has made that I can remember.” A Congressional investigation later found that the FDA's process for approving Aduhelm had been “rife with irregularities” and involved “protocol errors,” including an unusually close collaboration with Biogen.
Doctors also worried about the drug's serious safety risks, especially in light of its uncertain benefit. Aduhelm can cause brain swelling or cerebral hemorrhage.
Concerns were so great that Medicare moved to sharply limit coverage of Aduhelm, making it available only to patients in clinical trials. Medicare covers Alzheimer's drugs with full approval, which Aduhelm lacked.
Aduhelm grossed just $7.8 million in its first year and a half on the market. Since then, Biogen's revenue from the drug has been so small that the company no longer reports the details.
Biogen said Wednesday it did not act because of concerns about the drug's safety or effectiveness. Now the rights to Aduhelm go back to the Swiss company Neurimmune, which licensed the drug to Biogen.
Biogen will continue to provide monthly infusions of the drug to patients in the commercial market through November and to patients in the confirmatory clinical trial through May. On November 1, Biogen's license to sell the drug in the United States will be revoked.
Since its approval, Aduhelm has been replaced by two Alzheimer's drugs that have been shown to slow cognitive decline somewhat, but which doctors say may not have enough of an effect to be noticeable by patients or families.
Biogen and its partner Eisai, a Japanese pharmaceutical company, last year received approval for a drug, Leqembi, that is gradually being prescribed to more patients. Eli Lilly is expected to soon receive approval for another drug, donanemab.
Pam Belluck reporting contributed.