The US Food and Drug Administration (FDA) has granted Priority Review status to Takeda Pharmaceuticals USA, Inc's Biologics License Application (BLA) for its new investigational drug vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis.
A BLA was submitted in June 2013 seeking approval for vedolizumab for the treatment of adults with moderately to severely active Crohn’s disease (CD) or ulcerative colitis (UC). The application submitted for vedolizumab for the treatment of adults with moderately to severely active CD will be reviewed by the FDA under the standard review timeline.
An application can receive Priority Review designation if it is for a drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. Priority Review status allows for an eight month review period from the date of submission, compared to the standard review period of 12 months.
“Additional treatment options are needed for ulcerative colitis, and the acceptance for Priority Review of vedolizumab underscores this need,” said Karen Lasch, MD, medical director - GI, Medical Affairs, US Region, Takeda. “Takeda is excited about the potential for vedolizumab and, if approved, the possibility of providing a new treatment option for people with CD and UC.”
CD and UC are the two most common types of inflammatory bowel disease (IBD), and can be both painful and debilitating, sometimes leading to serious complications. While CD and UC treatment options are available, many patients may not achieve or maintain remission of their disease.
The BLA filings were supported by the GEMINI studies, a four-study clinical programme investigating vedolizumab in 2,700 patients in nearly 40 countries, making it the largest phase III clinical trial programme conducted to date simultaneously evaluating both CD and UC. Enrolled patients had failed at least one conventional therapy, including glucocorticoids, immunomodulators and/or a tumour necrosis factor-alpha (TNF-a) antagonists. TNF-a antagonist and conventional therapy failure patients included those with inadequate response (primary non-responders), loss of response (secondary non-responders) or those who were intolerant.
Phase III study results for vedolizumab were published recently in the New England Journal of Medicine.
The GEMINI studies is a phase III programme evaluating the effect of vedolizumab on clinical response and remission (along with effect on mucosal healing in UC), and long-term safety in moderately to severely active CD and UC patients who had failed at least one conventional therapy or a TNFa antagonist. This programme consists of four separate studies – a placebo-controlled induction and maintenance study in patients with UC (GEMINI I), a placebo-controlled induction and maintenance study in patients with CD (GEMINI II), a placebo-controlled induction study in patients with CD with prior TNF-a antagonist failure (GEMINI III) and an open-label long-term safety study in patients with either CD or UC (GEMINI LTS).
Vedolizumab, under development for the treatment of CD and UC, is a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 (a4ß7) integrin, inhibiting the binding of a4ß7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The a4ß7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in CD and UC.
Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.