Policy & Regulation
US Food and Drug Administration Accepts Takeda's Biologics License Application for a Subcutaneous Formulation of Vedolizumab for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
13 May 2019 - - The US Food and Drug Administration has accepted for review a Biologics License Application for a subcutaneous formulation of vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis, Japanese drugmaker Takeda Pharmaceutical Company Ltd. (TSX: 4502) (NYSE: TAK) said.

Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.

"Acceptance of this regulatory submission for review brings us one step closer to our goal of better meeting the diverse needs of patients with ulcerative colitis in the US.

The availability of a subcutaneous option for maintenance therapy with vedolizumab, in addition to the currently approved intravenous formulation, would provide physicians and patients with greater flexibility on route of administration, if approved," said Uthra Sundaram, senior vice president, GI Business Unit, Takeda Pharmaceuticals USA., Inc.

The application is based on the pivotal VISIBLE 1 phase 3 study, which assessed the safety and efficacy of a SC formulation of vedolizumab as maintenance therapy in 216 adult patients with moderately to severely active UC who achieved clinical response at week six following two doses of open-label vedolizumab intravenous therapy at weeks 0 and 2.1 The results of VISIBLE 1 were presented at the 2018 United European Gastroenterology Week Congress in Vienna, Austria.

In evaluating the primary endpoint of VISIBLE 1, a statistically significant proportion of patients receiving vedolizumab SC 108 mg maintenance therapy administered every two weeks achieved clinical remission compared to patients receiving placebo (46.2% vs. 14.3%; p