Eisai/Biogen’s Leqembi Sees Clear Path To Regular Approval For Alzheimer’s Disease
US FDA will ask its advisory committee to weigh anti-amyloid drug’s benefit-risk in populations at higher risk for adverse events, but agency says lecanemab’s risks ‘do not appear to preclude traditional approval’ and the CLARITY AD trial demonstrated clinical efficacy and a reduction in brain amyloid.
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Back-to-back US FDA advisory committee reviews of applications for a novel RSV antibody and a breakthrough Alzheimer’s therapy are a quietly remarkable testament to the resilience of drug development – and the flexibility of FDA – through the COVID pandemic.
US FDA agrees with Eisai/Biogen that half a point change in cognitive scale, which sponsor says means a five month delay in decline, is a clinically meaningful benefit. But others contend the treatment effect is small and does not outweigh risk of brain bleeds.
To get regular approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.