A Controversial Alzheimer’s Drug Pulled from Market: What Went Wrong?

In a surprising move, pharmaceutical company Biogen announced that it would be discontinuing its Alzheimer’s drug, Aduhelm, after it was awarded accelerated approval by the US Food and Drug Administration (FDA) in June 2021. The decision to approve the drug was highly contentious, as the FDA overruled its own independent advisors who had found insufficient evidence of its benefit. This decision caused three members of the independent committee to resign, and it was later revealed that the accelerated approval process was “rife with irregularities.”

Biogen stated that the discontinuation of Aduhelm was to redirect resources towards Leqembi, another Alzheimer’s medicine that had received full approval under the traditional regulatory pathway the previous year. Christopher Viehbacher, president and CEO of Biogen, emphasized the importance of breakthrough discoveries like Aduhelm in paving the way for future medicines and reinvigorating investments in the field. While Aduhelm was not successful in meeting expectations, its impact on the development of new treatments cannot be ignored.

Aduhelm is a monoclonal antibody designed to target the build-up of a protein called amyloid beta in the brain tissue, which is believed to contribute to the development and progression of Alzheimer’s disease. The drug underwent two late-stage human trials, showing a reduction in cognitive decline in one study but not the other. This inconsistent evidence left many experts skeptical about its efficacy.

According to a congressional report from December 2022, the FDA’s approval process for Aduhelm was anything but typical. The agency initially considered the drug under the traditional approval pathway, which usually takes several months for most drugs. However, in a surprising turn of events, the FDA abruptly changed course and granted accelerated approval to Aduhelm after a mere three-week review period. This sudden shift raised concerns about the integrity of the approval process.

The report highlighted several irregularities and collaborations between the FDA and Biogen that were deemed inappropriate. There were failures to properly document interactions between FDA staff and the drug maker, and the two entities collaborated on a joint briefing document for a key advisory committee. These irregularities and lack of transparency deeply compromised the credibility of the FDA’s approval process.

The congressional panel also shed light on Biogen’s financial motives behind Aduhelm. The company viewed the drug as an unprecedented financial opportunity, estimating a potential peak revenue of $18 billion per year. This staggering figure, coupled with an unjustifiably high price of $56,000 per year for patients, raised ethical concerns about prioritizing profit over patient welfare.

With the discontinuation of Aduhelm, Biogen’s Leqembi, developed in collaboration with Eisai of Japan, remains the only FDA-approved treatment for Alzheimer’s. Like Aduhelm, Leqembi targets amyloid beta and has shown modest success in reducing cognitive decline in patients with early-stage disease. Donanemab, a drug developed by Eli Lilly, may be the next candidate to receive approval, as it has demonstrated similar efficacy in clinical trials.

It is important to remember that Alzheimer’s is the most prevalent form of dementia, affecting more than one in nine individuals over the age of 65. The condition progressively worsens over time, robbing patients of their memories and independence. The urgent need for effective treatments is underscored by the staggering number of people affected by this devastating brain disorder.

The controversial approval and subsequent discontinuation of Aduhelm raise serious questions about the integrity of the FDA’s decision-making process and the prioritization of financial interests over patient welfare. While the journey to finding effective treatments for Alzheimer’s disease continues, it is crucial that regulatory bodies maintain transparency, adhere to rigorous evaluation standards, and prioritize the well-being of patients above all else. Only through these efforts can we hope to conquer this debilitating condition and bring relief to the millions of individuals and families affected by it.