FDA Signals Support for Eisai-Biogen Alzheimer's Drug Data Confirms Benefits For Complete Approval

FDA Peripheral and Central Drugs Advisory Committee is meeting Friday (June 9) to discuss a supplemental marketing application for Leqembi (lecanemab) submitted by Eisai Co Ltd ESALY for Alzheimer's disease, initiated in patients with mild cognitive impairment or mild dementia stage of the disease.

The Leqembi application has been granted Priority Review, with a Prescription Drug User Fee Act action date of July 6.

Eisai is collaborating with Biogen Inc BIIB for lecanemab.

The Adcomm will discuss whether the data from the Phase 3 Study 301 (CLARITY AD) confirm the clinical benefit of lecanemab for Alzheimer's disease.

Wednesday, the FDA released briefing documents ahead of the meeting that appears to support a full FDA approval for Leqembi.

In the study, Leqembi was tested against a placebo in patients with mild cognitive impairment due to Alzheimer's or mild Alzheimer's dementia. 

The study measured the drug's efficacy on an endpoint called the Clinical Dementia Rating-Sum of Boxes at 18 months of treatment.

On that primary endpoint and three secondary clinical endpoints, Leqembi met the mark in the trial, the FDA said.

As for safety, the agency flagged risks of amyloid-related imaging abnormalities, cerebral hemorrhages, and infusion-related reactions. But the reviewers concluded that the "risks can be described in the prescribing information and do not appear to preclude traditional approval of lecanemab." 

Reuters notes that traditional approval is expected to boost demand for Leqembi with broader insurance coverage under the U.S. government's Medicare plan.

Price Action: BIIB shares are up 1.46% at $309.34 premarket on the last check Thursday.

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