After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.
During a Friday meeting, members of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee took a careful look at the data behind the partners' Alzheimer's disease drug. Ultimately, the group voted 6 to 0 that the drug's Clarity AD study verify its clinical benefit.
In the discussion portion of the meeting, advisory committee members described the trial results as "robust," "meaningful," "consistent" and "significant."
Now, it's up to the FDA to decide whether to follow the advisory committee's guidance. The agency is expected to decide on the application by July 5.
Before the Friday discussion, the FDA released its own briefing document that appeared to outline agency support for a full approval. During the meeting, the FDA's acting director of the office of neuroscience, Teresa Buracchio, M.D., said the drug’s clinical trial data “provide a compelling case for a clinically meaningful effect of lecanemab for patients with Alzheimer’s disease."
Leqembi won an accelerated FDA approval in January based on its ability to reduce amyloid beta plaque, a marker of Alzheimer’s disease that's believed to be associated with improved outcomes.
But thanks to Medicare coverage restrictions, the launch won't really gain steam until the drug secures a full FDA approval.
For that full nod, the partners submitted data showing the drug's benefit on an endpoint called the Clinical Dementia Rating-Sum of Boxes after 18 months of treatment. The scale rates the severity of dementia to diagnose and assess a patient's condition.
The committee's recommendation came despite some calls during the public comment portion of the meeting—including from Public Citizen and Georgetown University's PharmedOut—for the drug's rejection. Many others supported an approval during the public comment section of Friday's meeting. Some commenters raised concerns about treatment side effects.
If the drug does score a full FDA approval, that'd allow the partners to kick off their U.S. launch in earnest. Under the current rules from the Centers for Medicare and Medicaid Services, new Alzheimer's treatments carrying accelerated approvals can only be covered in clinical trial settings to ensure ongoing collection of data.
Last week, the agency proposed wider coverage of the drugs once they gain full FDA approvals under a registry system to allow for real-world data collection. Still, the agency's registry plan has prompted criticism from industry trade group PhRMA, which has argued the approach raises barriers to access.
Leqembi is Biogen and Eisai's second Alzheimer's drug after their failed first offering Aduhelm. That drug won an accelerated FDA approval in 2021 and never gained market traction due to skepticism around its data and the CMS coverage restriction.