Yakult's Japan Duvelisib Decision Casts New Shadow Over Shrinking Pharma Ops

Generics Already A Major Challenge

05 Oct 2022

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.

Yakult has been facing challenges in its pharmaceutical business — Japanese beverage giant faces pharma business challenges • Source: Shutterstock

The recent concerns in the US over the risk-benefit balance for phosphatidylinositol 3-kinase (PI3K) inhibitors have cast a new shadow over the pharmaceutical business of diversified Japanese firm Yakult Honsha Co. Ltd., which is already seeing declining mainstay sales due to generic competition.

Shortly after an Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration decided the risk-benefit of Secura Bio, Inc