The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of a subcutaneous (under-the-skin) injection of Entyvio (Vedolizumab), the gut-selective maintenance therapy for adults with moderately to severely active Crohn’s disease and ulcerative colitis.
The recommendation brings Takeda Pharmaceuticals‘ new SC formulation of Entyvio one step closer to becoming the only self-administered maintenance therapy that can be given at home instead of at the hospital.
The company plans to make Entyvio SC available in both a pre-filled pen and a pre-filled syringe.
“Today’s positive CHMP opinion marks a key step forward in our goal to provide greater options to patients with ulcerative colitis and Crohn’s disease,” said Adam Zaeske, head of Takeda’s GI franchise for Europe and Canada, in a press release. “Ulcerative colitis and Crohn’s disease are life-long diseases, and it is important that patients have treatment options that suit their different preferences and lifestyles.”
“We look forward to the European Commission’s decision and the opportunity to bring a subcutaneous formulation of vedolizumab to these patients across Europe,” Zaeske said.
The Phase 3 VISIBLE 2 clinical trial (NCT02611817) assessed the safety and efficacy of the SC formulation of Entyvio as maintenance therapy.
Results showed that 48% of participants with moderately to severely active CD, who responded to two doses of intravenous (IV) (into-the-vein) Entyvio treatment after six weeks and were then assigned 108 mg of SC maintenance Entyvio every two weeks, achieved remission after one year — defined as a Crohn’s Disease Activity Index (CDAI) score of less than 150.
Data from Takeda’s VISIBLE 1 Phase 3 clinical trial (NCT02611830) for those with ulcerative colitis, published in February, was considered by CHMP as well. As in the VISIBLE 2 trial, people with moderately to severely active UC were first given two doses of intravenous Entyvio.
Those who achieved a clinical response — defined as a drop in Mayo score of more than three points and greater than 30% from baseline, along with a decrease in rectal bleeding subscore of more than one point or absolute rectal bleeding subscore of less than one point — were then given 108 mg of SC Entyvio every two weeks, IV Entyvio 300 mg every 8 weeks, or placebo, for one year.
Clinical remission was achieved by 46.2% of UC participants on SC maintenance therapy, compared with 42.6% on IV Entyvio, and 14.3% on placebo.
CHMP also evaluated the results from a long-term, open-label extension Phase 3 clinical trial (NCT02620046) to test the long-term safety and tolerability of maintenance SC Entyvio therapy in both UC and CD patients, which is currently underway.
That trial is assessing participants from the VISIBLE 1 and VISIBLE 2 trials who completed the 52-week maintenance period, those who achieved a clinical response to intravenous Entyvio after 14 weeks (instead of six weeks), and patients who withdrew or did not respond to treatment during the maintenance period.
Entyvio is approved as an IV therapy to treat adults with moderately to severely active ulcerative colitis and Crohn’s disease who fail to respond to other biological medicines or conventional therapies. It works by preventing pro-inflammatory immune cells from accessing the gastrointestinal tract.