Takeda Pharmaceutical Company Limited announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both syringe and pen options.
“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,” said Naoyoshi Hirota, Head of the Takeda Development Center 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 fulfill their needs.”
This NDA filing is based on the results of the VISIBLE 1 trial, a phase 3 clinical trial that evaluated the efficacy and safety of vedolizumab subcutaneous as maintenance therapy. In the VISIBLE 1 trial conducted in 216 adult patients with moderately to severely active ulcerative colitis, clinical response was obtained at week 6 following two doses of open-label intravenous administrations of vedolizumab as an induction therapy at weeks 0 and 2. The results of the VISIBLE 1 trial 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 subcutaneous 108 mg maintenance therapy administered every two weeks achieved clinical remission compared to patients receiving placebo (46.2% vs. 14.3%; p<0.001) at week 52. A similar rate of clinical remission was observed in the vedolizumab intravenous 300 mg reference arm (42.6%) at week 52. Adverse event rates, including severe adverse events and infections, were similar in the vedolizumab subcutaneous and intravenous groups at week 52. Injection-site reactions were generally mild and experienced by 10.4% of patients in the vedolizumab subcutaneous treatment arm (vs. 0% in the placebo group), with none leading to treatment discontinuation.