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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