Pharma Focus Asia

Takeda Pharmaceutical Announces Approval to Manufacture and Market Entyvio® Subcutaneous Injection

Tuesday, March 28, 2023

Takeda Pharmaceutical announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of Entyvio® Pens for subcutaneous (SC) injection 108 mg / Syringes for SC injection 108 mg (generic name: vedolizumab (Genetical Recombination), development code: MLN0002SC, hereinafter called “Entyvio SC”) as maintenance therapy for moderate to severe ulcerative colitis. Entyvio®should be used only in patients with inadequate response to conventional treatment.

Entyvio SC is intended to provide a dosing option that allows a choice of admistration method that best meets individual needs. SC delivery may reduce the number of personnel, equipment, facilities and time necessary for preparation of the intravenous formulation, which may minimise errors in administration of the drug. It is also intended to provide ease of handling, convenience, and reduce the time required per administration.

This approval provides ulcerative colitis patients and healthcare professionals with a wider range of dosage options to help meet diverse needs and improve quality of life.

Vedolizumab is a biologic agent that selectively acts on the gastrointestinal tract. It is currently approved as an intravenous formulation for the treatment of moderate to severe ulcerative colitis and the maintenance of moderate to severe ulcerative colitis and active Crohn’s disease.

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