Bristol-Myers Squibb Company — Zeposia EMA EPAR variation assessment report (EMEA/H/C/004835, 2020)
Bristol-Myers Squibb Company · 2020 · EMA EPAR variation assessment report · company profile →
Report summary
This report details Bristol-Myers Squibb's Type II variation application for Zeposia (ozanimod) to extend its indication to adult patients with moderately to severely active ulcerative colitis (UC). Preclinical studies demonstrated efficacy in reducing inflammation. Clinical trials (RPC01-202, RPC01-3101) showed significant improvements in clinical remission, endoscopic improvement, and mucosal healing compared to placebo during induction and maintenance phases. Pharmacokinetic and pharmacodynamic analyses confirmed dose-dependent effects and exposure-response relationships. The safety profile, assessed across UC and MS studies, revealed common adverse events like lymphopenia, nasopharyngitis, and elevated ALT, along with cardiac effects (bradycardia, blood pressure changes) and infections. Despite these safety concerns, the benefit-risk assessment for Zeposia in UC was deemed positive, leading to regulatory recommendations for marketing authorization variations.
Key findings — cited to the page
| Incidence of CTCAE Grade 4 ALC reductions < 0.2 x 10^9/L (ozanimod) | 1.1 % | · p.200 |
| Grade 4 ALC decrease to <0.2 x 10^9/L | 3 % | Pool Fm · p.190 |
| Incidence of CTCAE Grade 4 ALC reductions < 0.2 x 10^9/L (ozanimod-ozanimod group) | 3.0 % | · p.200 |
| Incidence of CTCAE Grade 4 ALC reductions < 0.2 x 10^9/L (Pool G) | 5.3 % | · p.200 |
| Proposed Indication | Ozanimod is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. | Zeposia · p.9 |
| Recommended Dose | 0.92 mg mg | Zeposia · p.9 |
| Dose Escalation Day 1-4 | 0.23 mg mg | Zeposia · p.9 |
| Vedolizumab dose greater than indicated | 25 % | United States · p.11 |
| Variation Type | C.I.6.a - Change(s) to therapeutic indication(s) - Addition of a new therapeutic indication or modification of an approved one | Zeposia · p.7 |
| Submission Date | 24 November 2020 | Zeposia · p.7 |
| Infliximab dose greater than indicated | 37 % | United States · p.11 |
| Procedure Number | EMEA/H/C/004835/II/0002/G | Zeposia · p.1 |
Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →