27 May 2021 - - The US Food and Drug Administration approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease, US-based pharmaceutical company Bristol Myers Squibb (NYSE: BMY) said.

Zeposia, an oral medication taken once daily, is the first and only sphingosine 1-phosphate receptor modulator approved for patients with moderately to severely active UC.

The mechanism by which Zeposia exerts therapeutic effects in UC is unknown but may involve the reduction of lymphocyte migration into the intestines.

It is thought that by targeting S1P receptors on lymphocytes, a type of immune system cell, Zeposia reduces the number of lymphocytes in peripheral blood.

The approval is based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC.

During induction at Week 10 (Zeposia N=429 versus placebo N=216) the trial met its primary endpoint of clinical remissiona (18% versus 6%, p