Alzheimer's drug approval raises the alarm
Data shows treatment can lead to 'brain shrinkage'
The US Food and Drug Administration (FDA) has granted an accelerated approval of a new treatment for Alzheimer’s disease, which aims to clear toxic amyloid protein build-up in the brain.
At a cost of $26,500 per year in the US (not covered by Medicare or Medicaid), people with early Alzheimer’s disease can receive a twice-monthly monoclonal antibody infusion called lecanemab (marketed as LEQEMBI™), co-developed by Eisai, a Japanese biotech firm, and Biogen.
In the lead up to the FDA’s approval, there was intense lobbying for the drug.
A ‘consensus statement’ signed by over 200 scientists, many of whom had financial ties to the drug companies, described lecanemab as a “foundational gamechanger” for the disease, calling for “no barrier” to the widespread availability of the treatment.
Now that the drug has been approved, advocacy groups like the Alzheimer’s Association, which are heavily funded by the drug industry, have welcomed the news, saying the FDA made “the right decision.”
But critics doubt the benefits of lecanemab outweigh its harms, and are dismayed that the FDA approved the drug without input from its own advisory panel.
Kim Witczak, a drug safety advocate, and member of the FDA’s Psychopharmacologic Drugs Advisory Committee, says she is “shocked" by the latest FDA stunt.
“By approving this new drug without a public advisory committee meeting, the FDA once again has shown a lack of concern for the public, patients, and healthcare providers. Convening its advisory panel would have helped reassure everyone that the FDA’s decision was scientifically sound and transparent,” said Witczak.
“Advisory committee meetings offer the opportunity to discuss the data in an open and public forum, to challenge methods, study endpoints (surrogate vs clinically meaningful), and safety findings before the general committee member discussion. But in this case, none of that was possible,” she added.
FDA repeating its mistakes?
The FDA’s accelerated approval process used to green-light lecanemab is known for accepting lower evidentiary standards for drug efficacy, so that patients can gain access to experimental drugs sooner.
Critics say its reminiscent of the FDA’s approval of aducanumab - Biogen’s other Alzheimer’s drug. It was approved on the basis of lowering amyloid protein (a surrogate marker) in the brain, despite no clinically meaningful benefit for patients.
At the time, the controversial decision led to the resignation of FDA advisory member Aaron Kesselheim, who labelled it “probably the worst drug approval decision in recent U.S. history.”
Linda Furlini, a research ethics advisor based in Montreal, Canada says it essentially gives the rubber stamp to similar drugs down the track. “Once you grant accelerated approval of a drug in that class, then it’s easier to get the second drug, and then the third drug approved.”
Jessica Adams, an expert in drug regulatory affairs, agrees. She said, “Lecanemab’s approval shows the power of precedent in regulatory approvals. This is why I scoff whenever the FDA says it still reviews drugs on a case-by-case basis.”