Biogen, the drug maker behind the controversial Alzheimer's drug Aduhelm, announced on Wednesday that it would be abandoning its ownership rights to the drug. Aduhelm had faced intense criticism from both the public and regulators due to its approval based on weak evidence of its efficacy. The drug was initially projected to be taken by millions of Alzheimer's patients and bring in billions of dollars in revenue, but it failed spectacularly in the marketplace.
The decision by Biogen marks the end of a long and contentious saga that has eroded trust in the regulatory process for new medicines. One FDA adviser even called the approval of Aduhelm "the worst approval decision that the FDA has made that I can remember." A congressional inquiry later found that the FDA's process for approving the drug had been "rife with irregularities" and involved close collaboration with Biogen.
Safety concerns surrounding Aduhelm were also significant, with doctors highlighting the drug's potential to cause brain swelling or bleeding. These concerns led Medicare to sharply limit coverage of Aduhelm, making it available only to patients in clinical trials. As a result, the drug brought in only $7.8 million in its first year and a half on the market, and Biogen no longer reports revenue details for the drug.
Biogen stated that its decision to abandon Aduhelm was not due to any concerns about its safety or effectiveness. The rights to the drug will now return to Neurimmune, the Swiss company that originally licensed it to Biogen. Biogen will continue to supply monthly infusions of Aduhelm to patients in the commercial market until November and to those in the confirmatory clinical trial until May. After November 1, Biogen's license to sell the drug in the United States will be withdrawn.
Since the approval of Aduhelm, two other Alzheimer's drugs, Leqembi and donanemab, have emerged as potential treatments. Leqembi, which Biogen is helping Eisai sell, has already received full FDA approval and has been shown to somewhat slow cognitive decline. However, doctors have noted that the effect may not be significant enough to be noticeable to patients or their families.
Biogen's decision to discontinue Aduhelm comes as a blow to the company, which had hoped for its success. The company will now shift its focus to other treatments for Alzheimer's. Biogen's shares rose following the announcement, indicating investor optimism about the company's future endeavors in the Alzheimer's space.
