Takeda Receives Approval to Manufacture and Market Entyvio Subcutaneous Injection in Japan for the Maintenance Treatment of Moderate to Severe Ulcerative Colitis
Takeda Pharmaceutical Company Limited 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.
This approval is based on the MLN0002SC-3027 and MLN0002SC-3030 clinical trials, which are international Phase III trials to evaluate the efficacy and safety of Entyvio SC as a maintenance therapy.
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 minimize errors in administration of the drug. It is also intended to provide ease of handling, convenience, and reduce the time required per administration.
Approved indications or effects, dosage and administration
| Brand name | Entyvio Pens for S.C. Injection 108mg / Syringes for S.C. Injection 108mg |
| Generic name | vedolizumab(Genetical Recombination) |
| Indications or effects | Maintenance therapy for moderate to severe ulcerative colitis (The drug should be used only in patients with inadequate response to conventional treatment.) |
| Dosage and Administration | The usual adult dose of vedolizumab (genetical recombination) for subcutaneous injection is 108 mg/dose once every 2 weeks. |
“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.