Takeda submits Biologics License Application for Vedolizumab

Takeda has submitted a new Biologics License Application for Vedolizumab, which is being used to treat moderate to severe Chohn’s Disease (CD) and Ulcerative Colitis in the US.

The application has been sent to the US Food and Drug Administration, with over four million people across the world affected by inflammatory bowel disease, with CD impacting up to 700,000 people.

Crohn’s Disease and ulcerative colitis are chronic diseases that cause inflammation of the lining of the digestive tract, with this potentially involving all areas of the digestive tract.

On the other hand, UC typically affects the colon and rectum. CD and UC can be painful and debilitating, which can occasionally result in serious complications.

Although CD and UC treatment options are on offer, many patients may not achieve or maintain remission of the condition.

William J Sandborn, M.D., chief, division of gastroenterology & professor of medicine, University of California San Diego School of Medicine, said: “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-recognised.

“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 backed by the Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS.

The first of these 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.

On the other hand, GEMINI II was designed to analyse the efficacy and safety of vedolizumab for inducing and maintaining clinical response and remission in patients with CD ranging from moderately to severely active.

CD and UC are the two most common forms of inflammatory bowel disease and Vedolizumab is being used as a humanised monoclonal antibody that antagonises the alpha4beta7 integrin.

Posted by Fiona Griffiths