The agency previously approved Rekembi, developed and manufactured by Eisai and Biogen, and accelerated approval earlier this year before evaluating late-stage clinical trial data. The data showed that the drug modestly delayed cognitive decline in trial participants compared to placebo, but could have serious side effects, including brain swelling and bleeding.
The Centers for Medicare and Medicaid Services said that under accelerated approval, only people participating in randomized clinical trials are eligible for Rekembi, but there are no enrollees. The Medicare coverage determination runs counter to the Veterans Health Administration, which said: it will cover the medicine for the beneficiary without limits.
Approximately 6.7 million people in the United States have Alzheimer’s disease, and there are few treatments for the disease. Biogen’s drug Aduhelm, which received early approval in 2021, works like Lekembi by targeting a protein thought to be one of the causes of disease. However, limited Medicare coverage and patient and caregiver concerns over evidence of modest efficacy have led to little widespread adoption of both drugs. There are five existing treatments for Alzheimer’s disease, which treat some of the disease’s symptoms but cannot slow its progression.
“Today’s action is the first demonstration that a drug that targets an underlying disease process in Alzheimer’s disease has demonstrated clinical benefit,” said Teresa Brachio, acting director of neuroscience at the FDA’s Center for Drug Evaluation and Research. said in a statement. “This confirmatory study proves it to be a safe and effective treatment for people with Alzheimer’s disease.”
Lawmakers and advocacy groups are pressuring CMS to relax or eliminate restrictions on the use of Rekumbi and similar drugs to ensure maximum patient uptake. In June, CMS launched a national patient registry on its website, with only basic information about patients that doctors typically collect, such as whether a patient is taking certain medications that may increase the risk of side effects. announced to ask. and how the patient’s cognition progresses over time.
“The FDA’s decision allows CMS to provide broad coverage of this drug while continuing to collect data to help us understand how the drug works,” CMS Administrator Chiquita Brooks Rashua said in a statement.
What’s next: Eisai estimates that about 10,000 patients will receive Rekembi by the end of March 2024.
