FDA gives full approval for drug to treat Alzheimer’s

US regulators on Thursday gave full approval, for the first time, to a drug shown to modestly slow cognitive decline in people with early Alzheimer’s. The medicine, called Leqembi, carries risks of serious side effects, but has also given hope to millions affected by the memory-ravaging disease. The treatment will cost $26,500 a year per patient, according to Biogen, the Cambridge drug maker, and its Japanese business partner Eisai, which co-developed the medicine. After the closely watched decision by the Food and Drug Administration, Medicare administrators swiftly indicated the federal government will cover the costs of the medicine for enrollees who meet the insurer’s criteria: They must be diagnosed with mild Alzheimer’s disease and have documented evidence of beta amyloid, a sticky protein that forms plaques in the brains of some patients. Administered through an intravenous infusion every two weeks, Leqembi reduced cognitive decline by 27 percent compared to a placebo over an 18-month trial involving nearly 1,800 people who were in the early stages of the disease, a clinical study found. It remains to be seen how much the clinical results will translate into the quality-of-life improvements most meaningful to patients and their families, such as lengthening the time people with early Alzheimer’s can continue to drive or live independently. “Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” Teresa Buracchio, acting director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. Alzheimer’s patients, experts, and advocates hailed the approval and predicted it will spur the discovery of even better drugs. “This is truly a momentous occasion,” said Joe Montminy, 59, a Plymouth resident diagnosed with Alzheimer’s who said he will seek a Leqembi prescription. “It’s a time when there’s more hope than ever before in treating Alzheimer’s disease.” The FDA gave conditional approval to Leqembi in January, concluding that it significantly reduced levels of amyloid. That reduction, regulators said, indicated Leqembi would likely provide benefit to patients. But the Centers for Medicare and Medicaid Services, which administers federal health insurance for Americans over 65, declined to reimburse patients receiving the drug outside clinical trials until the FDA had conducted a more thorough review and granted full approval. — ROBERT WEISMAN and JONATHAN SALTZMAN