This week the FDA is expected to approve what many scientists and doctors believe is the first drug to show promise of 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 progression of the disease 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 careful monitoring of patients for months or years, including many brain scans. Those receiving lecanemab, which carries the brand name Leqembi, were twice as likely as placebo recipients in the major trial to suffer hemorrhaging or swelling in the brain. These incidents, related to the drug’s stripping away of amyloid proteins, were generally minor, but three deaths appear to have been caused by the drug.
With the FDA poised to give full approval to lecanemab and Eisai set to promote it to the primary care physicians who treat most …
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This week the FDA is expected to approve what many scientists and doctors believe is the first drug to show promise of 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 progression of the disease 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 careful monitoring of patients for months or years, including many brain scans. Those receiving lecanemab, which carries the brand name Leqembi, were twice as likely as placebo recipients in the major trial to suffer hemorrhaging or swelling in the brain. These incidents, related to the drug’s stripping away of amyloid proteins, were generally minor, but three deaths appear to have been caused by the drug.
With the FDA poised to give full approval to lecanemab and Eisai set to promote it to the primary care physicians who treat most …nnDiscussion:nn” ai_name=”RocketNews AI: ” start_sentence=”Can I tell you more about this article?” text_input_placeholder=”Type ‘Yes'”]