Approval of Alzheimer's treatment may be promising for patients

Approval of Alzheimer's treatment may be promising for patients

Health advisors Friday unanimously endorsed the full approval of a new, closely monitored Alzheimer's drug, a major step toward opening up insurance coverage for US seniors with the early stages of the disease.

Liquimbe won conditional approval from the US Food and Drug Administration in January based on preliminary findings indicating it could slow the progression of Alzheimer's disease by several months.

The FDA is currently reviewing more specific findings to decide whether the drug should receive the agency's full approval.

The decision carries additional significance because insurance companies have withheld payment for the treatment pending full approval from the Food and Drug Administration.

A panel of outside advisors voted (6-0) that a large company study confirmed the drug's benefits for patients with mild or early-onset Alzheimer's disease.

A non-binding vote amounts to a recommendation of full approval, and the FDA is scheduled to issue a final decision on the matter by July 6.

Previous initial approval

The initial approval of Liquimbe by the US Food and Drug Administration came through the agency's accelerated approval program, which allows early access to drugs based on laboratory or biological criteria that indicates they may help patients.

The drug, which was marketed by Esay and BiogenAidic, helped remove brain plaques that are a hallmark of Alzheimer's disease.

The committee reviewed more recent data from a study of 1800 patients in which people who took the drug showed a slightly lower rate of decline in measures of memory, judgment and other cognitive tests.

"For a disease like this where we don't have that many, these are meaningful changes for Alzheimer's patients," said Dr. Merritt Kudkovic of Harvard Medical School. "Having another couple of months in a high functional state is really helpful."

The FDA can technically withdraw drugs that have been approved through the fast track if their benefits are not confirmed, though regulators rarely take this step. Obtaining full approval allows drugs to remain on the market indefinitely.

The accelerated approval diversion process usually attracts little attention, and the FDA rarely calls on its advisors to influence such decisions.

Maguy Farah's horoscope predictions for the year 2023