By Arthur Allen, KFF Health News
The FDA on Thursday gave full approval to what many scientists and doctors say is the first drug to show promise in slowing the progression of Alzheimer’s disease.
But while patient advocates are celebrating, critics see it as the unfortunate triumph of a flawed theory of the disease’s cause and predict the rollout of the drug will aggravate racial disparities in elder care.
An FDA advisory panel last month voted 6-0 to support FDA approval of lecanemab, from the Japanese pharmaceutical company Eisai. In a clinical trial involving nearly 1,800 early-stage Alzheimer’s patients, the drug slowed the disease’s progression somewhat in those who got biweekly infusions, compared with those given a placebo.
But the drug didn’t reverse Alzheimer’s symptoms, and it will require carefully monitoring patients for months or years, including with brain scans. Those receiving lecanemab, which carries the brand name Leqembi, were twice as likely as placebo recipients in the major trial to have hemorrhaging or swelling in the brain. These incidents, related to the drug stripping away amyloid proteins, were generally minor, but three deaths appear to have been caused by the drug.
With the FDA approving lecanemab, Eisai is set to promote it to the primary care physicians who treat most dementia patients and critics are speaking out. Some say the drug, which Eisai plans to market for $26,500 a year, offers false hope. Others say any positive impact it has won’t benefit lower-income patients, who tend to be diagnosed too late for the drug to be effective and usually receive care in settings ill-equipped to handle the drug’s stringent requirements.
“The most likely consequence of this medication is to take resources and attention away from addressing basic supports for older adults with cognitive impairment,” said Maria Glymour, chair of the Department of Epidemiology at the Boston University School of Public Health.
The money…
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