FDA approves Zeposia to treat moderately to severely active ulcerative colitis.- BMS.

Zeposia, an oral medication taken once daily, is the first and only sphingosine 1-phosphate (S1P) 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 III 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<0.0001) as well as key secondary endpoints, including clinical response (48% versus 26%, p><0.0001), endoscopic improvement (27% versus 12%, p><0.0001) and endoscopic-histologic mucosal improvement (13% versus 4%, p><0.001) for zeposia versus placebo, respectively. during maintenance at week 52 (zeposia n="230" versus placebo n="227)" the trial met its primary endpoint of clinical remission (37% versus 19%, p><0.0001) as well as key secondary endpoints, including clinical response (60% versus 41%, p><0.0001), endoscopic improvement (46% versus 26%, p><0.001), corticosteroid-free clinical remissione (32% versus 17%, p><0.001) and endoscopic-histologic mucosal improvement (30% versus 14%, p><0.001) for zeposia versus placebo, respectively. decreases in rectal bleeding and stool frequency subscores were observed as early as week 2 (i.e.,1 week after completing the required 7-day dosage titration) in patients treated with zeposia.></0.001)></0.001)></0.001),></0.0001),></0.0001)></0.001)></0.0001)></0.0001),></0.0001)>