By Deena Beasley and Julie Steenhuysen

LOS ANGELES (Reuters) – The U.S. Food and Drug Administration on Thursday granted standard approval to Eisai and Biogen’s Leqembi for patients with Alzheimer’s disease, clearing the way for wider insurance coverage of the drug.

The FDA included its strongest safety warning for an approved drug, a “boxed warning” on its label that flags the risk of potentially dangerous brain swelling for Alzheimer’s drugs like Leqembi.

Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer’s patients.

It is the first Alzheimer’s treatment to achieve traditional FDA approval, a new milestone for a fatal disease that has eluded drugmakers’ efforts for decades. The agency granted approval after data showed that the treatment slows progression of the disease by 27% in patients in the earliest stages of Alzheimer’s.

“Today we believe is a triumph for the Alzheimer’s disease community, after so many years of hard work by so many scientists, physicians and clinical trial participants and their care partners,” Eisai’s U.S. chief executive, Ivan Cheung, said in an interview.

Leqembi received “accelerated” FDA approval in January based on its amyloid-clearing ability, but the U.S. government’s Medicare health plan for people aged 65 and over had questioned the benefits of that class of drugs and restricted coverage only to patients in a clinical trial.

Leqembi’s new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. It says the risk is higher in patients with two copies of a gene, APOE4, associated with Alzheimer’s, and that while genetic testing is highly recommended, it is not required.

The drug’s new label includes data showing that the use of certain anti-coagulants with Leqembi has been linked to a risk of brain hemorrhage.

The warning will also apply to Eli Lilly and Co’s donanemab, an experimental Alzheimer’s drug that was shown to slow cognitive decline by 35% in a late-stage trial, according to a press release issued in May. Full results from that study are expected later this month.

The Centers for Medicare & Medicaid Services in June said it would cover Leqembi once it achieved standard FDA approval, but would still link reimbursement to patient participation in a health agency database, known as a registry. Since Alzheimer’s is a disease of aging, most U.S. patients are Medicare-eligible.

Leqembi, which is given intravenously, has a U.S. list price of $26,500 per year.

Cheung said Eisai is expanding efforts to get health centers ready to use Leqembi, but declined to comment on how many patients have been treated with the drug so far.

“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,” Joanne Pike, Alzheimer’s Association president and CEO, said in a statement.

A committee of external advisers to the FDA recently recommended traditional approval of the drug after an agency staff report concluded it offered a meaningful benefit to patients and said safety concerns could likely be managed.

More than 6 million Americans have Alzheimer’s, according to the Alzheimer’s Association.

Eisai has estimated that amyloid-lowering drugs would be used in some 100,000 U.S. patients during Leqembi’s first three years on the market.

The first FDA-approved disease-modifying Alzheimer’s drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

(Reporting by Deena Beasley in Los Angeles and Julie Steenhuysen in Chicago; Editing by Bill Berkrot and Matthew Lewis)

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