The drug Liquimbe won conditional approval from the US Food and Drug Administration in January based on initial findings that 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 Food and Drug Administration is scheduled to issue a final decision on the matter by July 6, according to the Associated Press.
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 it indicates 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 1,800 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 a lot, these are meaningful changes for Alzheimer’s patients,” said Dr. Merritt Kudkovitch 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.
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