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Leqembi Safety Is Focus Of Three Postmarketing Requirements From US FDA

 
• By Sue Sutter

Required studies will assess the risks of ARIA and intracerebral hemorrhage, as well as safety in ApoE ε4 homozygotes. For the required registry-based study, the FDA suggests use of the ALZ-NET platform with no mention of CMS’ newly established registry, which may lack the level of detailed information needed to satisfy the drug regulator’s request.

Arrows on road
When Leqembi converted to full approval, Eisai traded a required confirmatory trial for three mandatory safety studies. • Source: Shutterstock

With the US Food and Drug Administration’s full approval of the Alzheimer’s drug Leqembi (lecanemab-irmb), Eisai Co., Ltd. traded a confirmatory trial requirement under accelerated approval for three mandatory postmarketing safety studies.

Key Takeaways

  • The FDA is requiring Eisai to conduct three postmarketing safety studies of Leqembi focused on concerns highlighted in labeling about ARIA, intracerebral hemorrhage and risks in ApoE ε4 homozygotes.

  • The agency suggests use of the ALZ-NET registry for a prospective, observational study, with no mention of CMS’ own registry established to satisfy the Medicare coverage with evidence development requirements

Exercising its drug safety authority under Section 505(o) of the Food, Drug and Cosmetic Act, the FDA is requiring Eisai to conduct three studies to assess the serious risks of Leqembi, including amyloid-related imaging abnormalities (ARIA), intracerebral

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