Biogen gains as Medicare to cover new Alzheimer’s drug with full FDA approval
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Biogen (NASDAQ:BIIB) shares bounced back Wednesday after a top Medicare official said that the agency would cover the new Alzheimer's treatment Leqembi (lecanemab) in the event of full US FDA approval.
Testifying before the House Subcommittee on Health, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure announced the decision on Wednesday amid lawmaker scrutiny over her agency's controversial coverage policy for Alzheimer's drugs.
"The people who will be eligible will be based on the FDA label," she said, adding, "When FDA approves the drug, whichever populations they say it is appropriate for, that will be the basis of which people will get the drug."
Rep. Nanette Barragan, (D-Calif.), asked for clarity: "So you're basically saying that all patients indicated for the drug lecanemab and any future therapies in the class will have coverage upon full approval?" "That's right," Brooks-LaSure replied.
Biogen shares closed up 2% Wednesday.
In January, the FDA granted accelerated approval for Leqembi (lecanemab), which was developed with Eisai (OTCPK:ESALF)(OTCPK:ESAIY) as a treatment for Alzheimer's. The agency is expected to decide on its full approval by July 6, the target action date for the companies' application seeking full approval for the anti-amyloid antibody.
Early this year, Lilly (LLY) failed to secure the agency's accelerated approval for its anti-amyloid agent, donanemab, for Alzheimer's.
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