Takeda Gets Approval in Japan for Entyvio Subcutaneous Injection

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Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

On March 27, 2023, Takeda Pharmaceutical announced that the Japanese Ministry of Health, Labour and Welfare has approved Entyvio (vedolizumab) in 108-mg pens for subcutaneous (SC) injection and 108-mg syringes for SC injection as maintenance therapy for moderate to severe ulcerative colitis.

Entyvio SC provides an alternative dosing option that allows for patients to choose the method of administration that best meets individual needs. According to a company press release, SC delivery may reduce the number of personnel, equipment, facilities, and time necessary to prepare an intravenous formulation. This reduction may minimize errors encountered in the administration of the drug. The SC delivery method is also intended to provide ease of handling and convenience and can reduce the time required per administration.

“We are delighted that the subcutaneous formulation of Entyvio has been approved. We believe that this approval will provide a wider range of dosing options for ulcerative colitis patients and healthcare professionals and will help meet their diverse needs and improve quality of life,” said Naoyoshi Hirota, general manager of Takeda Development Center Japan in the press release.