08 Jul 2023

The new era of Alzheimer’s treatment has arrived. In a historic decision, the U.S. Food and Drug Administration granted traditional approval to Eisai’s anti-amyloid antibody lecanemab July 6. Lecanemab becomes the first Alzheimer’s treatment to clear this bar since the approval of memantine 20 years ago. It is also the first AD immunotherapy to be converted from accelerated to traditional approval. The decision had been widely expected, after the agency’s advisory committee unanimously recommended approval June 9 (Jun 2023 news).

The AdComm’s main concern about the treatment was safety. The FDA largely followed the committee’s recommendations in its label. The label includes a boxed warning about the risk of ARIA, which is typically asymptomatic but can be serious. Due to the higher risk for APOE4 homozygotes, the label states that APOE genotyping should be done before prescribing lecanemab, but stops short of requiring it. The label also suggests caution when prescribing the drug to people taking anticoagulants, or with other risk factors for intracerebral hemorrhage. Ultimately, however, the agency left it up to patients and physicians to weigh the risks and benefits for themselves.

With the drug already on the market, why does traditional approval matter? Mainly, because it broadens insurance coverage for the treatment. The Centers for Medicare and Medicaid Services previously had restricted coverage for anti-amyloid antibodies with accelerated approval to clinical trials (Apr 2022 news). Traditionally approved antibodies, however, are covered as long as physicians enter treatment data into a national registry (Jun 2023 news).

In tandem with the FDA’s announcement, CMS described how the process will work, and debuted its registry. According to the agency, physicians need only submit a short form to obtain coverage for patients. The submitted data will be covered by HIPAA privacy protections, and will include clinical details such as cognitive and amyloid test results, whether the patient is taking anticoagulants or has other risk factors, and whether ARIA develops. The goal is to collect real-world data on the long-term risks and benefits of the treatment.—Madolyn Bowman Rogers