“Worst drug approval decision in recent US history”

pharmafile | June 30, 2021 | News story | Research and Development  

The FDA’s decision to accelerate approval for Aduhelm, the first new drug for Alzheimer’s in two decades, has been met with outrage, with many experts dubious over whether the drug actually works.

One of the three FDA panel members who quit, Dr Aaron Kesselheim of Harvard-affiliated Brigham and Women’s Hospital, wrote in his resignation letter that it was the “worst drug approval decision in recent US history”.

In addition, the US consumer advocacy group, Public Citizen, has called for the resignation of three more top FDA officials.

Michael Carome, Director of Public Citzen’s health research group, said: “The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”

The approval has called into question the motivations for approving the drug, as the data from the trials is unclear at best, and Biogen will be set to profit massively from its rollout – Aduhelm is priced at about $56,000 a year.

Additionally, Biogen, which recorded $4 billion in profit on $13.4 billion in revenue last year, is losing its grip on two of its leading drugs. Spinraza, a treatment for neuromuscular disorders, is facing competition from a new drug introduced by Roche, and Tecfidera, a multiple sclerosis drug, is subject to competition from generics reaching the market at lower prices than its brand-name version.

These developments cut Biogen’s product revenue by nearly $700 million last year, compared with 2019. It’s clear why approval for Aduhelm would be a big victory for the company.

Kesselheim wrote on Twitter: “Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval.”

Internal memos regarding the approval have been released by the FDA to offer some insight to the logic behind the approval.

Peter Stein, Director of the FDA’s Office of New Drugs, wrote in a memo detailing his support for approval: “The FDA, then, is faced with a situation where the available evidence on the clinical endpoints is short of what we would require for standard approval of aducanumab.

“At the same time, patients with [Alzheimer’s] have a serious, progressive, ultimately fatal disease, and are desperate for treatments.”

The WHO estimates that 50 million people around the world suffer with dementia, with Alzheimer’s contributing up to 70% of those cases. 10 million new cases are added every year.

Lilly Subbotin

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