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Eisai’s Lecanemab: US FDA Showed Flexibility On Clinical Endpoint Results, Safety Database Size

 
• By Sue Sutter

Alzheimer’s drug’s failure to meet Phase II endpoint did not preclude accelerated approval in light of statistically significant reduction in amyloid plaque and ‘generally consistent and favorable results on clinical endpoints.’ Size of six-month safety database also fell shy of ICH guidelines.

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FDA showed some flexibility on data requirements for lecanemab given the serious nature of Alzheimer's disease. • Source: Shutterstock

The US FDA exercised regulatory flexibility on Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb) in its evaluation of clinical efficacy data, and the size of the safety database, for the Alzheimer’s disease drug.

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New EU Approvals

 
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Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

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Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
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EU CHMP Opinions And MAA Updates

 
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