FDA grants first full approval for an Alzheimer’s drug in 20 years

Under accelerated approval, the Centers for Medicare and Medicaid Services said it would cover Leqembi only for those participating in a randomized clinical trial, of which none were enrolling. Medicare’s coverage determination was contrary to the Veterans Health Administration, which said it would cover the drug for its beneficiaries without restriction.

Roughly 6.7 million people in the U.S. have Alzheimer’s, and there are few treatments for the disease. Aduhelm, a drug from Biogen that received accelerated approval in 2021, works similarly to Leqembi but has received little uptake due to Medicare coverage restrictions, and patient and caregiver concerns over the evidence of its modest benefits. There are five existing treatments for Alzheimer’s that treat some of the disease’s symptoms, but do not slow the progression of the disease.

Lawmakers and advocacy groups have pressed CMS to reduce or eliminate coverage restrictions for Leqembi and drugs like it to ensure maximum patient uptake. In June, CMS said that it would make a national patient registry available on its website, and that it would ask physicians only for basic information about patients’ that they would typically collect — such as whether the patient is taking certain drugs that could increase the risk of side effects and how a patient’s cognition progresses over time.

What’s next: Eisai estimates that roughly 10,000 patients will receive Leqembi by the end of March 2024.