Eisai/Biogen’s Leqembi Sees Clear Path To Regular Approval For Alzheimer’s Disease
Executive Summary
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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