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 US.
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.
The application is based on the pivotal VISIBLE 1 phase 3 study, which assessed the safety and efficacy of a SC formulation of vedolizumab as maintenance therapy in 216 adult patients with moderately to severely active UC who achieved clinical response at week six following two doses of open-label vedolizumab intravenous therapy at weeks 0 and 2.1 The results of VISIBLE 1 were presented at the 2018 United European Gastroenterology Week Congress in Vienna, Austria.
In evaluating the primary endpoint of VISIBLE 1, a statistically significant proportion of patients receiving vedolizumab SC 108 mg maintenance therapy administered every two weeks achieved clinical remission compared to patients receiving placebo (46.2% vs. 14.3%; p
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval