Biogen has declared its decision to relinquish ownership and cease the sales of Aduhelm, a controversial drug used in the treatment of Alzheimer’s disease, which came under scrutiny subsequent to its approval in 2021.
Biogen cited the termination of a licensing agreement with Neurimmune, the entity holding the rights to the drug.
Aduhelm, recognized as the first drug for Alzheimer’s disease approved by the Food and Drug Administration (FDA) since 2003, specifically targets amyloid beta proteins that accumulate in the brains of individuals with Alzheimer’s.
The FDA’s accelerated approval of the drug in 2021 generated concerns within the medical community as it contradicted the advice of external expert advisers who contended that clinical trials had failed to demonstrate the drug’s effectiveness.
Two years prior to its approval, Biogen prematurely halted its trials due to inconclusive results, indicating that the drug did not exhibit a slowdown in the progression of Alzheimer’s.
Subsequently, both Biogen and the FDA collaborated in reassessing the data, ultimately determining the drug’s efficacy, leading to the FDA’s conditional approval.
Biogen Faces Backlash Over $56,000 Drug Price Tag
Biogen encountered criticism for initially pricing the drug at $56,000 annually.
The company, headquartered in Cambridge, Massachusetts, subsequently reduced the price by half; however, detractors argued that it remained excessively costly for a drug unproven in its ability to mitigate memory and cognitive issues.
In a statement on Wednesday, Biogen announced the discontinuation of a post-approval study for Aduhelm, a requirement imposed by the FDA for the drug’s approval.
Nevertheless, Biogen affirmed its commitment to ongoing research and development of potential treatments for Alzheimer’s disease. Collaborating with Tokyo-based Eisai, Biogen secured FDA approval for Leqembi last year—a drug that targets amyloid beta and demonstrated a deceleration in the progression of Alzheimer’s in clinical trials.
Eisai led the development of Leqembi and retains the ultimate decision-making authority for the drug.