Takeda: Application to FDA on ulcerative colitis med advances

• An additional treatment modality would provide more flexibility in how patients receive vedolizumab, a biologic with a gut-selective mode of action
• Vedolizumab set to be the only maintenance therapy to offer the option of intravenous or subcutaneous formulations for patients with ulcerative colitis

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a subcutaneous (SC) formulation of vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.

“Acceptance of this regulatory submission for review brings us one step closer to our goal of better meeting the diverse needs of patients with ulcerative colitis in the U.S. The availability of a subcutaneous option for maintenance therapy with vedolizumab, in addition to the currently approved intravenous formulation, would provide physicians and patients with greater flexibility on route of administration, if approved,” said Uthra Sundaram, Senior Vice President, GI Business Unit, Takeda Pharmaceuticals U.S.A., Inc.

https://www.marketscreener.com/TAKEDA-PHARMACEUTICAL-CO-6491073/news/Takeda-Pharmaceutical-U-S-Food-Drug-Administration-Accepts-Takeda-s-Biologics-License-Applicati-28566842/