EMA Advances Under-the-skin Injection of Entyvio for Crohn’s and Ulcerative Colitis

EMA Advances Under-the-skin Injection of Entyvio for Crohn’s and Ulcerative Colitis

The European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for a new subcutaneous (under-the-skin) form of Entyvio (vedolizumab).

Entyvio is a biologic agent developed by Millenium Pharmaceuticals (now part of Takeda Pharmaceuticals) for the treatment of adult patients with moderate-to-severe ulcerative colitis (UC) or Crohn’s disease (CD). The medication is normally administered through an intravenous injection every eight weeks. However, it now will be possible to administer Entyvio by subcutaneous injections, using either pre-filled syringes or a pen injector.

“This regulatory application marks an important milestone in our continued commitment to delivering innovative medicines and treatment modalities that meet the diverse needs of patients living with ulcerative colitis and Crohn’s disease across Europe,” Adam Zaeske said in a press release. Zaeske is the head of GI Franchise, Europe and Canada Business Unit, Takeda,

“If approved, a subcutaneous formulation of vedolizumab, together with the currently available intravenous option, will provide greater choice, enhancing the patient experience in line with their treatment preferences and lifestyle,” Zaeske added.

The application submitted to the EMA was based on data from the pivotal Phase 3 clinical trial (NCT02611830), called VISIBLE 1. The study’s findings were presented last year at the 2018 United European Gastroenterology (UEG) Week Congress, in Vienna, Austria.

The trial was designed to evaluate the safety and effectiveness of Entyvio administered subcutaneously (108 mg, every two weeks) as a maintenance therapy in a group of 216 adult patients with moderate-to-severe UC who already had achieved a meaningful clinical response after receiving two doses of intravenous Entyvio, compared to a placebo.

Meaningful clinical response is defined as a reduction in complete MAYO score greater than three, with a decrease in rectal bleeding subscore greater than one. Clinical remission, however, is defined as a complete MAYO score of two or less points and no individual subscore  greater than one point.

Results showed that a significantly higher proportion of patients treated with subcutaneous Entyvio achieved clinical remission, compared to those treated with a placebo (46.2% vs 14.3%), at week 52.

The rate of clinical remission was similar to the one observed among patients who were treated with intravenous Entyvio (300 mg, every eight weeks) at week 52 (42.6%).

Adverse events (side effects) were similar in patients treated with the subcutaneous and intravenous forms, and none required patients to interrupt treatment. Mild injection-site reactions were experienced by 10.4% of patients in the treatment group and none in the placebo group.

Besides results from VISIBLE 1, Takeda also included in the application interim data from other studies involving patients with CD, including VISIBLE 2 (NCT02611817) and an open-label extension study (NCT02620046). All studies are part of the VISIBLE clinical trial program.