The European Commission has approved a subcutaneous (under-the-skin) formulation of Entyvio (vedolizumab) for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).
This decision, which follows a positive recommendation from the Committee for Medicinal Products for Human Use, means that the formulation is now approved in the 27 member states of the European Union, as well as the United Kingdom, Norway, Liechtenstein, and Iceland.
The medication will be made available in both a pre-filled syringe and a pre-filled pen.
Entyvio, marketed by Takeda Pharmaceuticals, is an approved treatment for UC and CD that works by stopping inflammation-driving cells from getting into the gut. The therapy was previously available only by intravenous injection.
The new subcutaneous formulation is more amenable to at-home treatment as it’s generally easier to administer and requires less expertise to do so safely.
“We are delighted that the European Commission has approved the subcutaneous formulation of Entyvio. This allows physicians and adult patients to choose the delivery method that works best for each individual patient,” Adam Zaeske, head of GI Franchise, Europe and Canada business unit, at Takeda, said in a press release.
“Takeda’s commitment to treating gastrointestinal disease means that we are always looking to innovate to provide further therapeutic options to better meet the needs of the patients we serve.”
The new approval was based on data from two Phase 3 trials — VISIBLE 1 (NCT02611830) in UC and VISIBLE 2 (NCT02611817) in CD — which evaluated the safety and efficacy of the subcutaneous formulation in participants with moderately to severely active disease. Collectively, these Takeda-sponsored studies enrolled more than 1,000 participants.
Both studies used clinical remission as the main efficacy measurement (endpoint). For UC, remission was defined as a decrease in Mayo score of more than three points and greater than 30% from baseline, accompanied by a decrease in rectal bleeding. For CD, remission was defined as a Crohn’s Disease Activity Index score of less than 150.
Results showed remission rates of 46.2% for UC and 48% for CD after one year on subcutaneous Entyvio. These rates were significantly higher than for participants given a placebo, and they were comparable to rates achieved with the intravenous formulation.
The European Commission’s decision also took into account data from an ongoing open-label extension study (NCT02620046) that enrolled participants who completed the VISIBLE trials.
According to Takeda, the subcutaneous formulation of Entyvio has been submitted for regulatory review by other authorities around the globe.