FDA clears Takeda’s Entyvio injection for Crohn’s disease

2024-04-19

临床3期上市批准临床结果

The subcutaneous (SC) version of Takeda’s Entyvio (vedolizumab) scored its second US win on Thursday when the FDA approved the gut-selective α4β7 integrin inhibitor α4β7 integrin inhibitor as maintenance therapy for Crohn’s disease. The regulator gave the injectable a green light for ulcerative colitis (UC) last September.

The approval for SC Entyvio, which can now be given to adults with moderately to severely active Crohn’s disease after induction therapy with an intravenous (IV) formulation, is based on results of the Phase III VISIBLE 2 trial. The study randomised 409 patients to receive either the biologic or placebo every two weeks, following induction. About 48% of patients with Crohn’s disease who received SC Entyvio were in clinical remission at week 52 compared with 34% for the placebo arm, achieving statistical significance.

The label expansion might help improve sales of the single-dose prefilled pen, which have been hampered by insurer pushback due to its high cost. However, a key opinion leader told FirstWord in February that in a year’s time, there is “a good chance” half of the IV Entyvio patients with UC will be on the SC formulation. For more, see KOL Views Q&A: Takeda's SC Entyvio sees slower than expected uptake in UC.

The EU cleared SC Entyvio for Crohn’s disease and UC in 2020.

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