There ’ s Finally a Fully Approved Alzheimer ’ s Drug —But Getting It Won ’ t Be Easy

It’s a decision that millions of people affected by Alzheimer’s disease and their families have been waiting for—the first fully approved drug that treats the disease, rather than its symptoms. On July 6, the U.S. Food and Drug Administration (FDA) granted full approval for lecanemab, or Leqembi, to treat Alzheimer’s in people in the early, mild stages of the neurodegenerative condition. Doctors can already prescribe lecanemab, which is made by Eisai Inc. and Biogen, since it has been available under accelerated approval from the FDA since January, but that conditional approval has limited access. The Centers for Medicare and Medicaid Services (CMS), which operates Medicare, decided in response to the accelerated approval that it would not cover the $26,500 yearly cost of lecanemab unless people were part of a clinical trial that continues to gather safety and effectiveness data on the medication. CMS said it will only reimburse for the drug outside of studies if the drug receives full FDA approval, which it now has, and people enroll in a registry that requires doctors to continue to report safety and effectiveness data for their patients using it. [time-brightcove not-tgx=”true”] The registry requirement makes the approval a bittersweet victory, say some patient advocates. “It is a hallmark, and something we should be celebrating with champagne dinners,” says Jim Taylor, co-founder of Voices of Alzheimer’s, a patient adv...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized healthscienceclimate Neuroscience Source Type: news