Takeda’s ulcerative colitis treatment gets US FDA priority review status

5th September 2013 (Last Updated September 5th, 2013 18:30)

Takeda Pharmaceuticals USA, a subsidiary of Japan-based Takeda Pharmaceutical Company, has secured priority review status from the US Food and Drug Administration (FDA) for the biologics license application (BLA) for its new investigational drug vedolizumab.

Ulcerative colitis

Takeda Pharmaceuticals USA, a subsidiary of Japan-based Takeda Pharmaceutical Company, has secured priority review status from the US Food and Drug Administration (FDA) for the biologics license application (BLA) for its new investigational drug vedolizumab.

Vedolizumab, which is under development for the treatment of Crohn's disease (CD) and ulcerative colitis (UC), is a humanised monoclonal antibody that specifically antagonises the alpha4beta7 (a4ß7) integrin, inhibiting the binding of a4ß7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1).

The new drug will be used for the treatment of adults with moderately to severely active CD and UC, which are the two most common forms of inflammatory bowel disease (IBD).

Takeda had submitted its BLA in June 2013 for the approval of vedolizumab, which will be reviewed by the FDA under the standard review timeline.

Takeda gastrointestinal medical director, medical affairs US region Karen Lasch said if vedolizumab is approved there will be a possibility of providing a new treatment option for people with CD and UC.

"Additional treatment options are needed for ulcerative colitis, and the acceptance for priority review of vedolizumab underscores this need," Lasch said.

"Additional treatment options are needed for ulcerative colitis, and the acceptance for priority review of vedolizumab underscores this need."

The BLA filings for the new 'vedolizumab' were supported by the Gemini Studies, which is a four-study clinical programme, that investigated the drug in 2,700 patients in about 40 countries.

The GEMINI programme comprises four distinct 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).

Priority Review status cuts down the standard review period by four months and it is usually granted to drugs indicated for a serious condition and which, if approved, provide a significant improvement in safety or effectiveness.


Image: Histopathological image of the active stage of ulcerative colitis. Photo: courtesy of KGH.