FDA grants first full approval for an Alzheimer’s drug

A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)

OAN’s Geraldyn Berry
1:45 PM –Friday, July 7, 2023

For the first time in more than 20 years an Alzheimer’s medicine, from Eisai and Biogen (BIIB), has received standard FDA clearance.


The new Alzheimer’s drug, lecanemab, is being sold by its manufacturer Eisai under the brand name Leqembi.

Following the FDA’s clearance on Thursday, the Centers for Medicare and Medicaid Services (CMS) declared full coverage of the medication, Leqembi. An external FDA advisory council previously unanimously endorsed the medication, a twice-monthly infusion for early-stage Alzheimer’s.

Leqembi’s first approval was conditional, which hindered Eisai and Biogen’s ability to make money. Medicare patients were unable to acquire the medication unless they were prepared to pay out of pocket. When the Department of Veterans Affairs (VA) decided to pay for the therapy, the pressure started to lessen.

According to reports, the medication is intended for people who are suffering from the disease’s early stages. Medicare has stated that it will only pay for patients who are registered in a national registry that monitors patient side effects and outcomes over time to cover the drug’s costs, which total more than $26,000 per year. A handful of the hundreds of thousands of Alzheimer’s patients who are qualified for the medication, according to some professionals and patient advocacy groups, may be able to receive it.

CEO of patient advocacy group, the Alzheimer’s Association, Joanne Pike, said in a statement that access to the drug is one of the association’s top priorities

“People living with this fatal disease deserve the opportunity to discuss and choose, with their doctor and family, whether an FDA-approved treatment is right for them,” Pike said.

Before reviewing findings from late-stage clinical study earlier this year, the organization previously gave Leqembi fast permission. The research showed that the medicine had moderately slower cognitive decline in study participants than a placebo, but it also had potentially harmful side effects, such as brain swelling and hemorrhage.

Leqembi would only be covered under fast approval, according to the Centers for Medicare and Medicaid Services, if the patient was enrolled in a randomized clinical study, which none were. The Veterans Health Administration had said that it would cover the medicine for its beneficiaries without limitations; Medicare’s coverage determination was in conflict with that statement.

Roughly 6.7 million people in the U.S. have Alzheimer’s, and there are few known treatments for the disease.

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