New FDA drug approval for IBD
The FDA has greenlighted monoclonal antibody vedolizumab for the treatment of moderate to severe Crohn’s and ulcerative colitis.
Last week’s approval is for patients who are refractory to current standard IBD treatments including corticosteroids, immunomodulators and anti-TNF drugs.
The Agency said it based its decision concerning ulcerative colitis on two trials involving 900 patients who had not responded to standard treatments. Those trials showed a greater proportion of patients treated with vedolizumab achieved and maintained corticosteroid-free remission, it said.