Takeda has received approval from the US Food and Drug Administration (FDA) for subcutaneous (SC) administration of Entyvio (vedolizumab) to treat moderately to severely active ulcerative colitis (UC) in adults.
The SC treatment is indicated for usage as maintenance therapy in UC patients following induction therapy with intravenous (IV) Entyvio.
Takeda plans to make SC doses of Entyvio available in the region as a single-dose pre-filled pen (Entyvio pen) by the end of October 2023.
The latest regulatory approval is based on findings from the Phase III VISIBLE 1 clinical trial that evaluated the efficacy and safety of Entyvio SC.
Trial data showed that 46% of the subjects in the Entyvio SC arm attained clinical remission at week 52, versus 14% with placebo.
The safety profile of the SC dose of Entyvio in these trials was in line with the reported safety profile of Entyvio IV.
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Takeda US gastroenterology business unit senior vice-president and head Brandon Monk stated: “With the FDA approval of subcutaneous Entyvio, patients and physicians who want Entyvio’s clinical profile along with the flexibility of administration now have two choices for maintenance treatment for adults with moderate to severe ulcerative colitis.
“Entyvio is the only FDA-approved biologic for maintenance therapy in ulcerative colitis offering the option of either intravenous or subcutaneous administration.”
The FDA is presently reviewing a biologics licence application for Entyvio SC to treat active moderate to severe Crohn’s disease.
Vedolizumab SC is also approved for use in the EU and more than 50 other countries.
The latest development comes after the FDA accepted for review the company’s new drug application resubmission for TAK-721 to treat eosinophilic esophagitis.