Takeda’s Entyvio Receives the US FDA’s Approval for Subcutaneous Administration to Treat Moderately to Severely Active Crohn’s Disease (CD)
Shots:
- The US FDA gives a nod to SC formulation of Entyvio for maintenance therapy in adults with moderately to severely active CD after Entyvio (IV) induction therapy
- The approval was based on VISIBLE 2, a P-III study, evaluating Entyvio SC (108mg, q2w) as maintenance therapy in patients (n=409); the study achieved long-term clinical remission (48% vs 34%) at 52wk with a CDAI score ≤150, along with consistent safety profile as of Entyvio IV
- Entyvio SC has received marketing authorization in 50+ countries and Entyvio IV is approved in 70+ countries, including the US and EU
Ref: Takeda | Image: Takeda
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.