Takeda said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a subcutaneous (SC) formulation of vedolizumab for use in active ulcerative colitis (UC) or Crohn’s disease (CD).
Takeda proposes to make vedolizumab SC available in both a pre-filled syringe and a pre-filled pen.
The positive opinion from the CHMP was based on the pivotal phase 3 VISIBLE trials which assessed the safety and efficacy of an SC formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active UC or CD who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2.1,2,3. Data from a long-term, open-label extension study of
patients from VISIBLE 1 and VISIBLE 2 was also considered.