Takeda ulcerative colitis biologic receives FDA approval

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO^® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis.

Subcutaneous (SC) administration is authorised for US adults with moderate to severe active ulcerative colitis (UC) after induction therapy with ENTYVIO intravenous (IV).

“ENTYVIO is the only FDA-approved biologic for maintenance therapy in ulcerative colitis offering the option of either intravenous or subcutaneous administration,” stated Brandon Monk, Senior Vice President, Head, US Gastroenterology Business Unit at Takeda.

Takeda’s ulcerative colitis biologic

Vedolizumab is a humanised monoclonal antibody and alpha4beta7 integrin antagonist. The alpha4beta7 integrin is expressed on certain circulating white blood cells. Inhibition of alpha4beta7 integrin using vedolizumab could help prevent certain white blood cells to infiltrate gut tissues, research shows.

The biologic is approved for intravenous (IV) and subcutaneous (SC) administration. It is authorised in the US, EU as well as over 50 countries for subcutaneous administration. The intravenous route of administration for vedolizumab has been granted marketing authorisation in more than 70 countries, including the US and EU, Takeda noted.

FDA’s approval is based on the Phase III VISIBLE 1 study (SC UC Trial). This evaluated 162 patients randomised at Week 6 to receive either ENTYVIO SC 108mg or placebo by subcutaneous injection every two weeks.

Data showed that at at Week 52, 46 percent of patients who were given the biologic maintenance therapy achieved clinical remission. This was compared to versus 14 percent of patients who received placebo.

“The VISIBLE 1 trial demonstrated that ENTYVIO SC can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients,” commented Dr Bruce Sands, MSS, Chief of the Dr Henry D Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai.

ENTYVIO SC is anticipated to be available in the US by the end of October 2023.