FDA panel backs full approval of Alzheimer’s drug Leqembi

WASHINGTON — Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer’s drug, a major step toward opening up coverage for seniors in the United States. The United States has the early stages of a brain-robbing disease.

Potion, Leqembi, received Accept the condition from the Food and Drug Administration in January based on early results showing it can slow the progression of Alzheimer’s disease for several months. The FDA is now looking at the clearer results to decide if the drug should receive full agency endorsement.

The decision makes more sense because insurance companies have payment delay for infusion treatments until full FDA approval.

The FDA’s external advisory panel voted 6-0 that a large company study confirmed the drug’s benefit for patients with mild or early Alzheimer’s disease. The non-binding vote count is a recommendation for full approval, and the FDA is expected to make a final decision on the matter by July 6.

The FDA’s initial approval for Leqembi came through the agency’s accelerated approval program, which allows early access to drugs based on laboratory or biological measures that show they can helpful to the patient. The drug, marketed by Eisai and Biogen, has cleared the brain plaque that is a hallmark of Alzheimer’s disease.

The FDA panel reviewed more recent data from a study 1,800 patients in which people taking the drug showed a slightly slower rate of decline on measurements of memory, judgment, and other cognitive tests.

Dr Merit Cudkowicz of Harvard Medical School said: “For a disease like this that we don’t have much of, these are changes that make sense for patients with Alzheimer’s disease. “A few more months in a highly active state really makes sense.”

Drugs approved through the accelerated route could technically be withdrawn by the FDA if their benefits are not confirmed, although regulators rarely take that step. Gaining full approval allows the drug to be on the market indefinitely.

Typically, the expedited approval transitions attract very little attention, and the FDA rarely convenes its advisors to weigh in on such decisions.

But concerns about the cost and effectiveness of new plaque-targeting drugs like Leqembi have attracted renewed scrutiny of the process from academics, members of Congress and medical insurers. economic.

Medicare, the federal health program that covers 60 million seniors, has basically blocked coverage of Leqembi and a similar drug, Aduhelm, pending full FDA approval. That policy, with little precedent, was announced last year amid concerns that Aduhelm, which costs $28,000 a year, will increase the cost for Medicare recipients.

The federal program provides health insurance for the vast majority of people with Alzheimer’s, and private insurers tend to follow its lead.

Leqembi costs a similar $26,500 per year, and the small number of patients who receive it so far have mostly been out of pocket.

Facing pressure from Alzheimer’s advocates and patients, the administrator of Medicare, Chiquita Brooks-LaSure, has made it clear that the program will immediately begin covering the drug if it is approved by the FDA. completely.

But last week, she announced additional requirements even after Medicare coverage kicks in: All patients receiving the drug will need to enroll in a federal registry to monitor for safety and effectiveness. fruit of Leqembi. That approach is sometimes used for complex new medical devices, but is rarely used for drugs.

The move has been criticized by advocacy groups, including the Alzheimer’s Association, which has been lobbying the federal government for months to start paying for a drug it says could potentially help. thousands of Americans.

Leqembi is the first drug to be convincingly shown to slow down Alzheimer’s disease by targeting the underlying biology of the disease. The delay in progress amounts to about five months, and some experts disagree on whether that difference will be enough to meaningfully improve people’s lives.

But most FDA panelists were impressed with Eisai’s results, which they say show a significant difference in patients’ cognitive abilities and function, as well as reduce the burden on caregivers squirrel.

The study followed patients for 18 months using a scale of key indicators of cognitive function. At the end of the trial, patients receiving Leqembi declined more slowly – less than half a point on the scale – compared with patients receiving a dummy infusion.

This drug is also associated with possible serious side effects, including brain swelling and small bleeding in brain vessels.

Three patients taking Leqembi died during the study, two after suffering a stroke related to bleeding in the brain. But FDA reviewers say it remains unclear whether the drug plays a role in deaths from other underlying factors that affect patients, including drug use. Blood thinning can increase the risk of bleeding.

“There are side effects,” said Dr. Robert Alexander of the University of Arizona, who chaired the workshop. “But they are monitorable and I think the benefits are clear.”

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