In a surprising turn of events, pharmaceutical company Biogen has announced the discontinuation of its controversial Alzheimer’s drug, Aduhelm. The drug had received accelerated approval from the US Food and Drug Administration (FDA) in June 2021, a decision that sparked intense debate due to the agency’s overruling of its own advisors. This move was met with significant backlash, leading to the resignation of three independent committee members who had unanimously voted against recommending the drug. Congressional investigators even criticized the accelerated approval, calling it “rife with irregularities.”
Biogen made the decision to discontinue Aduhelm in order to redirect its resources towards Leqembi, a newer Alzheimer’s medicine that received full approval under the traditional regulatory pathway last year. Christopher Viehbacher, the president and CEO of Biogen, believes that Aduhelm paved the way for a new class of drugs and revitalized investments in the field. According to Viehbacher, “When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed.”
Aduhelm is a monoclonal antibody designed to target the accumulation of a protein called amyloid beta in brain tissue, which is believed to contribute to Alzheimer’s disease. It underwent testing in two late-stage human trials. While one of the studies did show a reduction in cognitive decline, the other did not produce the same positive results. Despite this mixed outcome, the FDA decided to grant accelerated approval to Aduhelm, which led to further scrutiny and criticism.
In a congressional report from December 2022, it was revealed that the FDA’s interactions with Biogen during the approval process were deemed “atypical.” The report highlighted the failure to properly document contacts between FDA staff and the drug maker, as well as an inappropriately collaborative effort between the two parties in creating a joint briefing document for a crucial advisory committee. These irregularities raised serious concerns about the integrity of the FDA’s approval process.
The congressional panel’s report indicated that Biogen saw Aduhelm as an unparalleled financial opportunity, estimating a potential peak annual revenue of $18 billion. This outlook, coupled with the drug’s steep price tag of $56,000 per year for patients, raised eyebrows and intensified the criticism surrounding Aduhelm. The high pricing was deemed unjustifiably high, adding fuel to the fire of public and congressional scrutiny.
With Aduhelm no longer available, Biogen’s Leqembi, co-manufactured with Eisai of Japan, remains the sole FDA-approved treatment for Alzheimer’s. Like Aduhelm, Leqembi also targets amyloid beta and has shown modest success in reducing cognitive decline in patients with early-stage disease. There is potential for another Alzheimer’s drug, Donanemab, developed by Eli Lilly, to receive approval after exhibiting similar results in clinical trials.
Alzheimer’s is the most prevalent form of dementia, affecting over one in nine individuals over the age of 65. The condition progressively worsens over time, robbing its sufferers of their memories and independence. The impact of Alzheimer’s on individuals and their loved ones cannot be overstated, making the development of effective treatments a crucial priority.
The discontinuation of Aduhelm marks a turning point in the ongoing controversy surrounding the drug’s approval and pricing. This decision by Biogen underscores the need for rigorous evaluation and transparency in the drug approval process to ensure the best possible outcomes for patients and to maintain public trust in the pharmaceutical industry. While the future of Alzheimer’s treatment remains uncertain, the hope for innovative and effective therapies continues to drive scientific research and investment.
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