Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502/NYSE: TAK) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both syringe and pen options.
“This NDA filing is an important step in our commitment to deliver innovative medicines and treatment modalities that meet the needs of patients living with ulcerative colitis in Japan,” said Naoyoshi Hirota, Head of the Takeda Development Center Japan. “By making it possible to select the treatment modality that suits a patient’s desired administration method and lifestyle, we are aiming to enhance the patient experience and help fulfill their needs.”
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