The US Food and Drug Administration (FDA) has approved ozanimod (Zeposia) for adults who suffer from moderate to active ulcerative colitis (UC), the company announced.
Ozanimod’s approval for UC is based on data from True North, a phase 3 placebo-controlled trial that evaluated medication in 645 adults (mean age, 42 years; 60% male) at moderate to severely active ulcerative colitis over 10 weeks.
All participants in the trial failed to respond adequately to or were intolerant to oral aminosalicylates, corticosteroids, immunomodulators, or a biologic; 30% had previously experienced treatment failure or were intolerant of tumor necrosis factor blockers. Before and during induction, patients were treated with oral aminosalicylates and/or corticosteroids.
Michael Chiorean said in a company news release, “In True North, Zeposia demonstrated efficacy for endpoints such as clinical remission, endoscopic and histological mucosal improvement, and safety. All are very relevant considerations for patients with ulcerative colitis”.
Michael Osso, president and CEO of Crohn’s and Colitis Foundation said in the release, “Ulcerative colitis can be debilitating and unpredictable for the people living with this chronic inflammatory bowel disease”. He further added in his statement, “The approval of this new oral treatment is welcome news for our community and provides hope to many patients who are looking for new options to achieve symptom relief and remission”.
Ozanimod is recently (last 6 months) contraindicated for patients with myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III / IV heart failure; Patients who have Mobitz type II second- or third-degree atrioventricular block, sick sinus syndrome, or sinoatrial heart block unless the patient has a functioning pacemaker; Patients with severe untreated sleep apnea; And patients taking monoamine oxidase inhibitors.
Ozanimod may increase the risk of infection. Before starting treatment, a complete blood count is required for all patients. Patients should be monitored for infection for up to 3 months during treatment and after stopping treatment. Treatment should not be started in the presence of active infection.
Source: MedScape