Takeda announced Friday that the European Commission has approved its filing for a subcutaneous (SC) formulation of Entyvio (vedolizumab) for use as maintenance therapy in adults with moderate-to-severe ulcerative colitis or Crohn's disease. Entyvio is already approved in intravenous form, with Takeda noting that the "additional treatment modality provides more options for how patients in Europe can receive the gut-selective biologic," which will be made available in both pre-filled syringes and pens.
The decision follows a positive opinion issued in February by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The approval was based on the Phase III VISIBLE trials, which assessed the SC formulation of Entyvio as maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn's disease who achieved clinical response at week 6 following two doses of intravenous Entyvio therapy at weeks 0 and 2. Takeda noted that data from an interim analysis of an ongoing, long-term extension study of patients in the VISIBLE 1 and VISIBLE 2 studies were also considered.
Aside from Europe, Takeda stated that the SC formulation of the gut-selective biologic is also approved in Canada.
Meanwhile, the original intravenous version of the drug was authorised by the FDA in 2014 for the treatment of certain adults with moderate-to-severe ulcerative colitis or Crohn's disease. However, Takeda's filing for the SC formulation was rejected by the US regulator in December. At the time, Takeda noted that in the complete response letter, the agency "posed questions unrelated to the clinical data and conclusions from the pivotal trial supporting the [biologics license application]." The Japanese drugmaker also said it would "work closely with the FDA on a path to approval."
In February, Takeda reported that Entyvio had generated sales of JPY 95.1 billion ($893 million) in its fiscal third quarter, up 31% from the year-ago period.
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