Yakult's Japan Duvelisib Decision Casts New Shadow Over Shrinking Pharma Ops
Generics Already A Major Challenge
Yakult’s decision to pull an approval application for duvelisib in Japan came shortly after a FDA advisory committee said it would re-evaluate the safety and efficacy of the PI3K inhibitor four years since its approval. The developments cast a new shadow over Yakult’s already-suffering pharmaceutical business.
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In concluding benefits do not outweigh risks in the drug’s current indication, US FDA advisory committee members cite concerns about survival data from the Phase III DUO trial, as well as the drug’s toxicities, safety issues with the PI3K inhibitor class, and the changing treatment landscape for chronic lymphocytic leukemia and small lymphocytic lymphoma.
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