The drug ozanimod, which is being developed by Bristol Myers Squibb under the name Zeposia, gained FDA and European Commission approval last year for multiple sclerosis.
With the priority review designation, ozanimod could be approved by the FDA by June, becoming a first-in-class oral medicine for ulcerative colitis. The drug works by acting on immune cells called lymphocytes that are centrally involved in the immune attack on the large intestine.
In the randomized and blinded clinical study, a far higher share of patients who took ozanimod experienced remission—and maintained remission at a higher rate—than those who received a placebo. The study also met endpoints for clinical response, noting a marked decrease in disease activity, and for “endoscopic improvement,” which refers to healing of the mucosal tissue in the colon and rectum.
“Results like this are gratifying to see, both for the medical community and for patients around the world who are in need of better options to manage this unpredictable disease,” says Hugh Rosen, MD, PhD, who invented ozanimod along with fellow Scripps Research Professor Edward Roberts, PhD, and their laboratory colleagues.
Ozanimod is also in late-stage clinical trials for the treatment of Crohn’s disease, another type of inflammatory bowel disease.