FDA panel weighs US approval for Alzheimer's drug from Eisai and Biogen

Leqembi won accelerated approval by the Food and Drug Administration in January based on its ability to remove toxic amyloid plaques from the brain. The agency is expected to make its decision on traditional approval by July 6.slowed cognitive decline

Several Wall Street analysts read the commentary in the FDA briefing documents as a sign that traditional approval was likely. UBS analyst Colin Bristow had said he expects Friday's panel meeting "to essentially be a formality" that will lead to approval and broaden access to the medicine. Patient advocacy groups expressed opposition to that plan, saying making Medicare coverage conditional to participation in a registry may reduce access to the drug.

FDA also wants input on the drug's use in patients taking blood thinners, and in those with a condition called cerebral amyloid angiopathy, in which the protein amyloid - which Leqembi targets - builds up in artery walls and can cause bleeding in the brain.A positive vote by the agency's advisers would be in sharp contrast to their rejection of Aduhelm, a controversial earlier Alzheimer's drug from Eisai and Biogen.

Source: Healthcare Press (healthcarepress.net)

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