Eisai Co. and Biogen Inc. moved closer to full US approval for their Alzheimer’s drug Leqembi after the Food and Drug Administration posted documents indicating it sees no barriers to clearance, setting the product up for likely government health-plan coverage.
(Bloomberg) — Eisai Co. and Biogen Inc. moved closer to full US approval for their Alzheimer’s drug Leqembi after the Food and Drug Administration posted documents indicating it sees no barriers to clearance, setting the product up for likely government health-plan coverage.
Studies suggest the drug shows a “consistently favorable” treatment effect, the FDA said in briefing documents posted Wednesday ahead of a meeting of outside advisers scheduled for Friday. Risks associated with the drug “can be described in the prescribing information and do not appear to preclude traditional approval of lecanemab,” the agency said.
The advisory committee will vote on whether study results support Leqembi’s use in Alzheimer’s treatment. The FDA is not bound to follow the committee’s recommendation, but often does. Analysts are expecting the drug, which is the first treatment shown to slow the progression of Alzheimer’s, to receive committee support and FDA approval.
“We see the most likely scenario as a positive adcom and subsequent full approval for Leqembi,” Wedbush analyst Laura Chico said in a note to clients.
Medicare, the US health program for the elderly, confirmed last week that Alzheimer’s drugs like Leqembi will be covered as soon as they receive full regulatory approval. The drug, now cleared only on an accelerated basis used to quickly get medications to in-need populations, could see more than $2 billion in annual US sales, according to Bloomberg Intelligence analysts Marc Engelsgjerd and Sam Fazeli.
Biogen, based in Cambridge, Massachusetts, rose as much as 3% in New York. Eisai jumped as much as 10% in Tokyo on Thursday morning, the biggest increase in eight months, to trade at the highest since July 2021.
The panel will also discuss the benefits and risks of using Leqembi, including in patients who need blood-thinning medications, although there’s no vote scheduled on the issue. The absence of a vote “emphasizes that the FDA is looking to the panel more for input on these topics that we sense physicians are already highly engaged in and debating themselves,” rather than recommendations, RBC Capital Markets analyst Brian Abrahams said. He expects the label will allow use in patients receiving blood thinners, but with warnings for clinicians about potential risks.
“Our first impressions suggest we should expect an uncontroversial panel on Friday that will end in a likely favorable vote with no major label narrowing,” Abrahams said in a note to clients.
–With assistance from Robert Langreth and Kanoko Matsuyama.
(Updates Eisai share price in sixth paragraph.)
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