The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for a subcutaneous (SC) formulation of vedolizumab as maintenance treatment for adult patients with moderately to severely active ulcerative colitis (UC).
Currently, vedolizumab, an integrin receptor antagonist, is available for administration as an intravenous infusion under the brand name Entyvio (Takeda). If the SC formulation is approved, Takeda proposes to make the product available in both prefilled syringe and pen options.
The BLA submission includes data from the VISIBLE 1 phase 3 study which assessed the safety and efficacy of the SC formulation as maintenance therapy in patients with moderately to severely active UC (N=216). Patients who achieved clinical response at week 6 following 2 doses of open-label vedolizumab IV therapy were randomized to vedolizumab SC 108mg and placebo IV, vedolizumab IV 300mg and placebo SC, or placebo SC and placebo IV.
Results showed a statistically significant proportion of patients receiving vedolizumab SC administered every 2 weeks achieved clinical remission (defined as a complete Mayo score of ≤2 points and no individual subscore greater than >1 point) at week 52 compared with placebo (46.2% vs. 14.3%; P <.001). Moreover, a similar rate of clinical remission was observed in the vedolizumab IV 300mg group (42.6%) at week 52. The safety profile of the SC formulation was consistent with that of vedolizumab IV.
“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 USA, Inc.
Vedolizumab IV is currently approved for the treatment of adult patients with moderately to severely active UC and Crohn disease.
For more information visit takeda.com.