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.
Lecanemab is already available to doctors, as it has had accelerated FDA approval since January. However, this conditional approval has restricted access. CMS, which runs Medicare decided to respond to the accelerated FDA approval by refusing to cover the $26,500 cost of lecanemab until people are enrolled in a trial to continue gathering safety and effectiveness data. CMS has said that it will reimburse the drug without studies only if it receives FDA approval. This drug now has. Patients must also enroll in a registry which requires doctors to report on safety and effectiveness for patients who use it.
The registration requirement is…