BRISTOL — Zeposia FDA Review (NDA/BLA 209899, 2023)
Bristol-Myers Squibb Company · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
Zeposia (ozanimod) was FDA-approved on May 27, 2021, for relapsing multiple sclerosis (MS) and moderately to severely active ulcerative colitis (UC) in adults, following a 7-day titration to a 0.92 mg daily dose. The approval was based on efficacy data from clinical trials, including significant improvements in clinical remission and other endpoints for UC patients compared to placebo. Safety concerns include bradyarrhythmia, liver injury, increased blood pressure, respiratory effects, macular edema, and potential immunosuppression. Postmarketing requirements include pregnancy outcome studies and a pediatric UC trial. The review also covered Zeposia's pharmacokinetics, drug interactions, and detailed safety analyses across various adverse events, confirming its benefit-risk profile for the approved indications.
Key findings — cited to the page
| PMR 4066-1 Interim Report #2 Submission | 06/2028 | Zeposia (Ozanimod) pregnancy registry study · Global · p.6 |
| Nausea | 2.8 % | Pool F · p.146 |
| Nausea | 1.8 % | Pool F · p.146 |
| PMR 4066-2 Interim Report #1 Submission | 06/2025 | Zeposia (Ozanimod) pregnancy outcomes study · Global · p.6 |
| Approval Date | May 27, 2021 | Zeposia (Ozanimod Hydrochloride) · p.1 |
| Indication | treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Moderately to severe active ulcerative colitis (UC) in adults. | Zeposia (Ozanimod Hydrochloride) · p.1 |
| sNDA submission date | November 30, 2020 | Zeposia (ozanimod) capsules · p.4 |
| Nausea | 14 patients | Pool F · p.146 |
| PMR 4066-1 Draft Protocol Submission | 11/2021 | Zeposia (Ozanimod) pregnancy registry study · Global · p.6 |
| PMR 4066-1 Final Protocol Submission | 06/2022 | Zeposia (Ozanimod) pregnancy registry study · Global · p.6 |
| PMR 4066-1 Interim Report #1 Submission | 06/2025 | Zeposia (Ozanimod) pregnancy registry study · Global · p.6 |
| PMR 4066-1 Study Completion | 06/2032 | Zeposia (Ozanimod) pregnancy registry study · Global · p.6 |
Source: Bristol-Myers Squibb Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →