Takeda Pharmaceutical has submitted a new drug application (NDA) in Japan for a subcutaneous (SC) formulation of vedolizumab to treat adults with moderately to severely active ulcerative colitis (UC).
The company proposes to make vedolizumab SC, a gut-selective biologic, available in the syringe, as well as pen options.
The NDA submitted to the Ministry of Health, Labour and Welfare is based on the results obtained from the Phase III VISIBLE 1 clinical trial that evaluated the efficacy and safety of vedolizumab SC as maintenance therapy.
Takeda Development Center Japan head Naoyoshi Hirota said: “This NDA filing is an important step in our commitment to deliver innovative medicines and treatment modalities that meet the needs of patients living with ulcerative colitis in Japan.
“By making it possible to select the treatment modality that suits a patient’s desired administration method and lifestyle, we are aiming to enhance the patient experience and help fulfil their needs.”
A total of 216 adult patients with moderately to severely active ulcerative colitis participated in the VISIBLE 1 trial.
Clinical response was obtained at week six after two doses of open-label intravenous administrations of vedolizumab as an induction therapy at weeks 0 and 2.
VISIBLE comprises three Phase III studies involving more than 1,000 UC and CD patients.
Two randomised, double-blind, placebo-controlled studies will examine the proportion of patients achieving clinical remission at week 52 and an open-label extension study would determine the long-term safety and efficacy of vedolizumab SC.
UC, a chronic, relapsing, remitting, inflammatory condition of the gastrointestinal (GI) tract, affects more than 220,000 people in Japan.