Zeposia

Zeposia (ozanimod) was approved on May 27, 2021, for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It is also indicated for moderately to severely active ulcerative colitis (UC) in adults. The recommended maintenance dosage is 0.92 mg orally once daily.

In clinical trials for ulcerative colitis, 18% to 37% of patients achieved clinical remission with Zeposia, compared to 6% to 19% in the placebo arms. Clinical response was observed in 60% of patients, versus 41% for placebo. Endoscopic improvement was seen in 46% of patients, compared to 26% for placebo. Corticosteroid-free remission was achieved by 32% of patients, while 17% of the placebo group achieved this. Among those who achieved remission at Week 10, 52% maintained clinical remission with Zeposia, compared to 29% in the placebo group.

Common adverse reactions (incidence ≥4%) for Multiple Sclerosis included upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension. For Ulcerative Colitis, common adverse reactions included increased liver tests, upper respiratory infection, and headache. The overall rate of infections in MS studies for Zeposia was 35%, with a 1% rate of serious infections. Zeposia typically causes a mean reduction of 45% in peripheral blood lymphocyte count from baseline values.