FDA Approves, Leqembi, New Treatment for Early Alzheimer’s

An F.D.A. official involved in the review of Leqembi said that “there were many important lessons learned” since the approval of Aduhelm.

With Leqembi, the F.D.A. included narrower and more cautionary language on the drug label than it initially had with Aduhelm. (After an outcry from physicians and others, it changed the Aduhelm label a month after its approval.)

The Leqembi label says the drug should be used only for patients in early and mild stages of Alzheimer’s disease, matching the status of patients in the clinical trials of the drug. It instructs doctors not to treat patients without doing tests to confirm that they have one of the hallmarks of Alzheimer’s: a buildup of the protein amyloid, which Leqembi (like Aduhelm) attacks.

“In the case of Leqembi, more detail and clarity on the most appropriate patient population for use of the drug, and greater explanation around safety” for brain swelling, brain bleeding and use of blood thinners with the drug are “now included in the label,” said the official, who spoke on condition of anonymity to describe agency deliberations.

The official said the F.D.A. also requested more data on subgroups of patients characterized by age, gender, health status and other factors, and that it worked with the companies to include more diversity in the clinical trials. Participants in the Aduhelm clinical trials were overwhelmingly white, but in the Leqembi trials about 25 percent of United States participants were Black or Hispanic.

Ivan Cheung, the chairman and chief executive of Eisai’s United States operations, said in an interview that in discussing who should be eligible for the treatment, “we have worked very hard with the F.D.A. to narrow the population down to a very specific one, the same as the clinical trials.”

About 1.5 million of the six million people with Alzheimer’s in the United States are estimated to be in the beginning phases of the disease, with diagnoses of either mild cognitive impairment or early-stage Alzheimer’s. How many will be treated with Leqembi will depend significantly on whether Medicare covers the drug.

Article source: https://www.nytimes.com/2023/01/06/health/alzheimers-drug-leqembi-lecanemab.html