Physician critiques new Alzheimer's drug approval
In an opinion piece published on MedPage Today, oncologist Vinay Prasad argues that the FDA's approval of lecanemab for Alzheimer's disease is premature and overlooks significant risks. He calls for more rigorous evidence before widespread use.
Vinay Prasad, MD, MPH, a hematologist-oncologist and professor at the University of California, San Francisco, published his critique in the 'Second Opinions' column on October 10, 2023. The piece focuses on lecanemab, branded as Leqembi, which received accelerated FDA approval in January 2023 and full approval in July 2023 for treating early-stage Alzheimer's disease.
Prasad highlights the drug's modest benefits, noting that the phase 3 Clarity AD trial showed a 27% slower cognitive decline over 18 months compared to placebo, based on the Clinical Dementia Rating-Sum of Boxes score. 'This translates to a difference of 0.45 points on a 0-18 scale,' he writes, emphasizing that such gains may not be clinically meaningful for patients.
He points to serious safety concerns, including brain swelling and bleeding in 13% of trial participants, with three deaths linked to the treatment. 'The risk-benefit ratio is unfavorable,' Prasad states, arguing that the approval prioritizes industry interests over patient safety.
Background context reveals lecanemab as a monoclonal antibody targeting amyloid-beta plaques, a hallmark of Alzheimer's. The FDA's decision followed lobbying from patient advocacy groups and pharmaceutical companies like Eisai and Biogen, despite mixed expert opinions. Prasad contrasts this with the rejection of aducanumab, another amyloid-targeting drug, in 2021 due to insufficient evidence.
Prasad advocates for stricter standards, suggesting that drugs should demonstrate clear clinical benefits, not just biomarker changes. He warns of potential overprescription and high costs—estimated at $26,500 annually—burdening healthcare systems without proven long-term value.
The opinion underscores ongoing debates in neurology about Alzheimer's treatments, where no disease-modifying therapies have succeeded despite decades of research. Prasad's view aligns with some experts who question amyloid hypothesis dominance, while supporters argue lecanemab represents progress for a devastating condition affecting over 6 million Americans.