Takeda’s subcutaneous vedolizumab proves efficacious in Phase III trial for Ulcerative Colitis
pharmafile | October 22, 2018 | News story | Sales and Marketing | Takeda, UC, biologic, phase III, results, ulcerative colitis, vedolizumab
Japanese pharma firm Takeda has announced that the gut-selective biologic vedolizumab when taken as a subcutaneous (SC) injection, proved efficacious in comparison to placebo in patients suffering from moderately to severely active ulcerative colitis (UC).
The therapy was proven effective in the Phase III VISIBLE 1 clinical trial in which 46.2% of patients given vedolizumab, compared to 14.3% of those given a placebo achieved clinical remission.
“The VISIBLE 1 results highlight that the investigational subcutaneous formulation of vedolizumab helped patients with moderately to severely active ulcerative colitis achieve and maintain clinical remission, mucosal healing and durable clinical response, after responding to vedolizumab IV induction therapy. These data indicate that the subcutaneous formulation of vedolizumab had an efficacy and safety profile similar to the IV reference arm, and further add to the collective dataset for vedolizumab in ulcerative colitis,” said Professor William J. Sandborn, lead investigator for the VISIBLE 1 trial and Director of the Inflammatory Bowel Disease Center at UC San Diego.
Adverse events were similar in comparison to vedolisumab IV injections with 9.4% of patients experiencing mild injection-site reactions.
“These results mark an important milestone for Takeda in our efforts to better meet the needs of patients with inflammatory bowel disease. We hope to make the subcutaneous formulation of vedolizumab available to provide more choice for patients and their physicians. The patient’s experience is very important to us, and we are committed to providing physicians with treatment options that suit the individual needs and preferences of their patients, whether that is intravenous or subcutaneous,” said Jeff Bornstein, Executive Medical Director, Takeda.
Louis Goss
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