FDA to Review SC Formulation of Vedolizumab for Ulcerative Colitis

The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for the investigational subcutaneous (SC) administration of vedolizumab (Entyvio^®) as maintenance treatment for adults with moderately to severely active ulcerative colitis (UC).

Vedolizumab, an integrin receptor antagonist, is currently available for administration as an intravenous (IV) infusion under the brand name Entyvio. In December 2019, the FDA issued a Complete Response Letter (CRL) to Takeda regarding the BLA for vedolizumab. The letter requested additional information related to the design and labeling of the SC device. 

The BLA submission is supported by data from the phase 3 VISIBLE 1 study (ClinicalTrials.gov Identifier: NCT02611830), which evaluated the safety and efficacy of the SC formulation as maintenance therapy in 216 adults with moderately to severely active UC. Findings from the study showed that treatment with vedolizumab SC administered every 2 weeks met the primary endpoint of clinical remission at week 52 (defined as a total Mayo score of ≤2 and no subscore of >1). A similar rate of clinical remission was observed in the vedolizumab IV 300mg group at week 52. The safety profile of the SC formulation was consistent with that of vedolizumab IV.

The Company expects a decision from the FDA by the end of 2023. “Takeda has remained committed to the pursuit of a subcutaneous administration for Entyvio in the US so that patients might have a choice between receiving Entyvio maintenance therapy via intravenous infusion by a health care professional or administering it themselves with a single-dose injection – whichever suits their medical and personal needs. This resubmission is a major step forward in delivering on that commitment,” said Vijay Yajnik, MD, PhD, vice president, head of US Medical for Gastroenterology, Takeda.