The US Food and Drug Administration (FDA) has accepted a filing from Japan-based Takeda (TYO: 4502) for a subcutaneous version of the alpha4beta7 integrin inhibitor Entyvio (vedolizumab). This new formulation is intended as a maintenance therapy for adult patients with moderately to severely active Crohn’s disease (CD) who have been induced with the intravenous formulation. The acceptance of the filing follows the product’s support from safety and efficacy results of a late-stage trial that successfully met its primary endpoint of clinical remission.
Subcutaneous Version Aims to Expand Treatment Options
The subcutaneous version of Entyvio offers a potential new treatment option for patients with Crohn’s disease, providing a non-intravenous alternative for maintenance therapy. This development is in line with Takeda’s commitment to improving patient access to innovative therapies and enhancing treatment experiences.
Ulcerative Colitis Submission Under Review
In addition to the Crohn’s disease filing, a similar submission for ulcerative colitis (UC) is currently under review by the FDA. This underscores Takeda’s broad development program for vedolizumab, aiming to address the needs of patients with both Crohn’s disease and ulcerative colitis, two forms of inflammatory bowel disease.-Fineline Info & Tech
