FDA Approves Takeda’s Subcutaneous Ulcerative Colitis mAb
Takeda has announced that its single-dose pen for ENTYVIO® (vedolizumab) – a monoclonal antibody medication for ulcerative colitis – has been approved by the as a treatment for the chronic inflammatory gut disease.
The pen is able to deliver the drug via subcutaneous injection and is approved for adults in the US with moderate to severe cases of the condition after an intravenous course of ENTYVIO.
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Takeda’s Senior Vice President and Head of their US Gastroenterology Business Unit, Brandon Monk, said: “ENTYVIO is the only FDA-approved biologic for maintenance therapy in ulcerative colitis offering the option of either intravenous or subcutaneous administration.”
After the encouraging news of its approval, it is predicted that subcutaneous ENTYVIO will be sold in the US by the end of October 2023.
About ENTYVIO® (vedolizumab) and its ‘VISIBLE 1’ Trial
The humanised antibody vedolizumab is an antagonist of alpha4beta7 integrin which is expressed on select T cells. By inhibiting these lymphocytes via the alpha4beta7 integrin pathway, vedolizumab stops them from infiltrating gut tissues.
The approval by the FDA comes after Takeda’s ‘VISIBLE 1’ phase III clinical trial of the subcutaneous administration of vedolizumab for ulcerative colitis. The trial enrolled 162 patients who either tool 108mg of vedolizumab subcutaneously or a placebo every two weeks.
Results from the study saw 46% of non-placebo patients achieving clinical remission by the 52nd week, while only 14% of patients from the placebo group achieved clinical remission.
“The VISIBLE 1 trial demonstrated that ENTYVIO SC (subcutaneous) can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients,” said Bruce Sands, Chief of the Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. Both intravenous and subcutaneous forms of the biologic are now approved in the US, EU, and over 50 further countries. Takeda already has marketing authorisation for the intravenous administration in over 70 countries, including the US and EU, it said.
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