مشاركات عشوائية

FDA approves new Alzheimer's drug that appears to slow disease

featured image

The Food and drug administration Friday approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the disease.

The approval offers patients new hope after repeated failures to find effective treatments, even though side effects have been reported with the new drug, experts say.

The drug, lecanemab, which will be sold as Leqembi, is a monoclonal antibody infusion given every two weeks.

The FDA has approved Leqembi for use in people with mild cognitive impairment or early-stage Alzheimer’s disease.

The drug was approved in an accelerated course, which enables the early approval of promising new drugs that “fill an unmet medical need”. At the same time, companies are required to conduct additional clinical trials to confirm the benefits of their drugs or risk their withdrawal from the market.

The agency said its decision was based on a mid-term trial of 856 patients with Alzheimer’s disease.

At the end of September, Eisai and Biogen, the companies that developed the drug, announced that a phase 3 clinical trial of 1,795 patients found Leqembi slowed cognitive decline in people who received it by 27% after 18 months. The FDA said Friday it plans to review Phase 3 data “soon”.

The FDA did not seek the advice of its advisory committee — which it did before controversially approving another Alzheimer’s drug developed by Biogen, called Aduhelm, in 2021.

Leqembi.
Leqembi.Eisai Co.

Leqembi is not a remedy; it aims to slow the progression of the disease by eliminating beta-amyloid clumps — long thought by scientists be one of the main causes of disease — of the brain.

The benefit is small, experts say, but adding anything that might give patients more time with family and loved ones is valuable.

The twice-weekly drug is expected to cost about $25,000 a year for a single patient, Ivan Cheung, Eisai’s U.S. chairman and CEO, told NBC News. The Centers for Medicare & Medicaid Services currently limits coverage for drugs that target amyloid in the brain, so uptake of the new drug may be limited at first, Cheung said.

Safety concerns have been raised about the drug. At least three dead may be drug related after patients experience brain swelling or brain bleeding.

According to to the company’s phase 3 trial data, about 12.6% of patients who received the drug experienced brain swelling, compared to only 1.7% of those in the placebo group. About 17% of patients who received the drug had a cerebral hemorrhage, compared to 9% in the placebo group.

Cheung said the company is still “confident” that the drug’s benefits outweigh its risks.

“The disease is devastating,” he said, “and comes with a lot of emotional turmoil in all the families involved.”

Alzheimer’s disease is the seventh leading cause of death in the United States, according to centers for disease control and prevention. Most FDA-approved drugs for Alzheimer’s disease are aimed at relieving symptoms, not slowing the progression of the disease.

Friday’s announcement follows a scathing Congressional report released last week detailing the approval of another Alzheimer’s drug, called Aduhelm. The drug, developed by Biogen, was approved in 2021 despite an FDA advisory committee finding that it was unlikely to work. In last week’s report, investigators said the agency failed to meet its own standards and that its approval of Aduhelm was “riddled with irregularities”.

In response to the report, Public Citizen, an advocacy group, sent a letter on Wednesday urging the FDA to postpone its decision on whether or not to approve Leqembi while the companies complete additional clinical trials necessary for full approval.

Drugs have defenders.

Donna Wilcock, assistant dean of biomedicine at the University of Kentucky, said Leqembi should be approved. The data supporting Leqembi’s candidacy is ‘strong’, she said, adding that the trial results are the best she has ‘ever seen for an Alzheimer’s drug. since I was 25″.

The Alzheimer’s Association said based on the results of Eisai and Biogen’s Phase 3 clinical trials, the FDA should approve Leqembi for early-stage Alzheimer’s disease.

The organization urges the Centers for Medicare & Medicaid Services to reconsider its decision on new treatments for Alzheimer’s disease. Last year, in response to poor data supporting Aduhelm’s approval, the CMS said it would not cover Alzheimer’s drugs that target amyloid unless patients participated in a clinical test.

Making the drug more widely available could mean more patients have “many more months to recognize their spouses, children and grandchildren,” said Maria Carrillo, scientific director of the Alzheimer’s Association.

In a statement released after the FDA’s approval on Friday, the CMS suggested it might reconsider its position on coverage for certain Alzheimer’s disease treatments.

“CMS is reviewing available information and may reconsider its current coverage based on this review,” the agency said.

CORRECTION: (January 6, 4:08 p.m. ET): A previous version of this article missed the stage of clinical trial data submitted to the FDA. The agency said its decision to approve Leqembi was based on a Phase 2 clinical trial, not Phase 3.

Follow BNC Health to Twitter & Facebook.

Post a Comment

0 Comments