Hot on the heels of an approval in the US, regulators in Europe have now also given Takeda's Entyvio (vedolizumab) the nod for two inflammatory bowel diseases.
The European Commission has granted Marketing Authorisation for use of the gut-selective humanised monoclonal antibody to treat adults with moderately to severely active ulcerative colitis (UC) and adults with moderately to severely active Crohn's disease (CD).
With this approval, Entyvio becomes the first and only biologic therapy to be approved simultaneously for these two conditions, in patients who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNF_) antagonist.
"In clinical trials, vedolizumab demonstrated statistically significant efficacy on a range of endpoints and was well-tolerated in trials for both UC and CD and we are pleased that the European Commission recognizes its clinical benefit," said Trevor Smith, Head of Commercial Operations, Europe and Canada, Takeda.
The drug is a novel alpha-4 beta-7 integrin antagonist which works by blocking a key inflammatory marker on white blood cells. Takeda acquired the drug with its $8.80 billion purchase of Millennium Pharmaceuticals in 2008, and a number of analysts believe the drug could attain blockbuster status.
Around 2.2 million people in Europe suffer from UC and CD, and while there is no cure for these diseases, new therapies are urgently needed to to help patients failing to respond to standard treatment better manage their disease and reduce symptoms.