ESALF - Eisai exec expects full approval of Alzheimer's therapy Leqembi this summer - CNBC

The U.S. CEO of Eisai ( OTCPK:ESALY ) said that the U.S. FDA could grant full approval of its Alzheimer's treatment Leqembi (lecanemab) as soon as July.

Speaking with CNBC, Ivan Cheung said, "We’re literally talking about maybe like five months away, so we are moving with urgency definitely with CMS right now."

Although Leqembi was granted accelerated approval by the FDA in January , full approval is crucial as it will likely impact whether CMS will cover the therapy for Medicare recipients.

"We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria," Cheung said .

One potential hiccup to Eisai ( OTCPK:ESALF ) and partner Biogen's ( NASDAQ: BIIB ) optimism is that current CMS policy says that monoclonal antibody therapies that target amyloid -- the protein in the brain thought to contribute to Alzheimer's -- are only covered in trials that are CMS authorized .

CMS is expected to make a National Coverage Determination on Leqembi by the end of the year.

The agency's severe limitation has greatly impacted sales of the companies' other Alzheimer's therapy, Aduhelm (aducanumab).

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