EU approves Zeposia for ulcerative colitis.
Zeposia, an oral medication taken once daily, is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Zeposia is the first and only oral S1P receptor modulator approved for UC, and represents a new way of treating this chronic immune-mediated disease.
The approval was 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 remission (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 remission (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. in the induction and maintenance phases of the true north trial, the overall safety profile was consistent with the known safety profile for zeposia and patients with moderate to severe uc.
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