The drug is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) and adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNF-alpha) antagonist.
Both UC and CD are affecting over four million people across the world, including about 2.2 million Europeans.
Takeda head of Commercial Operations, Europe and Canada Trevor Smith said the company is happy to receive the CHMP positive opinion for vedolizumab for ulcerative colitis and Crohn’s disease, as this recognition of the clinical benefit of vedolizumab brings us closer to providing the first gut-selective biologic agent for UC and CD to patients across Europe.
"With the development of vedolizumab, Takeda is building upon this heritage and expanding into innovative therapies with a new biologic treatment," Smith said.
The company had submitted a marketing authorisation application (MAA) to the EMA in March 2013 for vedolizumab to treat adults with moderately to severely active UC or CD.
The European Commission (EC) will now review the CHMP opinion for vedolizumab and if the CHMP is formally adopted by the EC, the drug would be approved for marketing in the 28 member states of the EU as well as Norway, Iceland and Liechtenstein.
The MAA is supported by the GEMINI Studies, a clinical program investigating vedolizumab in 2,700 patients across nearly 40 countries.
Image: Takeda’s Entyvio is indicated to treat ulcerative colitis (UC) and Crohn’s disease (CD). Photo: courtesy of cooldesign/ freedigitalphotos.net