Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that a Biologics License Application (BLA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for vedolizumab, an investigational humanized monoclonal antibody for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC), the two most common types of inflammatory bowel disease (IBD).
“The disease burden of IBD is quite significant in the United States, especially on the many young adults living with Crohn’s disease and ulcerative colitis,” said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. “This regulatory submission marks a significant step forward for vedolizumab in the U.S., and as a company we are excited about the possibility of providing this community with a new treatment option.”
More than four million people worldwide are affected by IBD, with CD affecting as many as 700,000 people and UC affecting as many as 700,000 people in the U.S.Crohn’s disease and ulcerative colitis are chronic diseases that cause inflammation of the lining of the digestive tract. Inflammation caused by CD can involve all areas of the digestive tract, while UC typically impacts the colon and rectum.CD and UC can be both painful and debilitating, which may sometimes lead to serious complications. While CD and UC treatment options are available, many patients may not achieve or maintain remission of their disease.
“CD and UC are chronic diseases that can negatively impact those who live with the associated challenges – and the need to seek new treatment options is well-recognized,” said William J. Sandborn, M.D., chief, division of gastroenterology & professor of medicine, University of California San Diego School of Medicine. “In clinical development, vedolizumab has demonstrated the potential to be another possible treatment option for people with moderately to severely active CD and UC.”
The BLA submission was supported by the Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which make up the GEMINI Studies™, a four-study clinical program to investigate the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients. Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators and/or a TNF-α antagonist. TNF-α antagonist failure patients included those with inadequate response (primary nonresponders), loss of response (secondary nonresponders) or those who were intolerant.Vedolizumab has been studied in 2,700 patients in nearly 40 countries, making it the largest Phase 3 clinical trial program conducted to date simultaneously evaluating both CD and UC.
GEMINI I was designed to assess the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with moderately to severely active UC in whom one prior therapy had failed. Key primary endpoints included clinical response at week six and clinical remission at week 52.
GEMINI II was designed to assess the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with moderately to severely active CD. Primary outcomes included the number of patients in clinical remission and enhanced clinical response at week six, and clinical remission at 52 weeks.
GEMINI III was designed to assess the efficacy and safety of vedolizumab for the induction of clinical response and remission in patients with moderately to severely active CD. The key primary endpoint included the proportion of patients in clinical remission with previous failure of anti-TNFα therapy.
GEMINI LTS is an ongoing open-label, long-term safety study of vedolizumab, and was designed to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab administration.