Pfizer Inc. — Velsipity EMA EPAR public assessment report (EMEA/H/C/006007, 2024)
Pfizer Inc. · 2024 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) has issued a positive opinion for Velsipity (etrasimod) for treating moderately to severely active ulcerative colitis (UC) in patients aged 16 and older who have not responded to or are intolerant of conventional or advanced therapies. Velsipity, the fifth S1P modulator licensed in the EU, is the first primarily for a non-CNS indication. Non-clinical studies detailed etrasimod's potent S1P1 receptor agonism, pharmacokinetics, and toxicology, including teratogenic effects and carcinogenicity (a class effect). Clinical trials demonstrated significant efficacy in achieving clinical remission, endoscopic improvement, and symptomatic remission at 12 and 52 weeks. Safety concerns, consistent with S1P modulators, include cardiovascular effects (bradycardia, AV block), hypertension, liver enzyme elevations, and macular edema. A comprehensive risk management plan is in place, and the benefit-risk balance is considered positive.
Key findings — cited to the page
| Histologic remission (RHI score ≤ 3, with scores of 0 (zero) for both Geboes Grade 2B (lamina propria neutrophils) and Grade 3 (neutrophils in epithelium)) (%) | 39.5 % | Study APD334-302 · p.123 |
| Histologic remission (RHI score ≤ 3, with scores of 0 (zero) for both Geboes Grade 2B (lamina propria neutrophils) and Grade 3 (neutrophils in epithelium)) (%) | 25.3 % | Study APD334-302 (Placebo) · p.123 |
| Grade 2 neutropenia (%) | 3.1-7.6 % | · p.173 |
| Grade 2 lymphopenia (%) | 8.4-14.6 % | · p.173 |
| Grade 4 lymphopenia (%) | 0.6-5.5 % | · p.173 |
| Grade 2 neutropenia (%) | 4.7-10.4 % | · p.173 |
| Infections in Grade 3 lymphopenia | 11 % | Study APD334-301 · p.164 |
| Grade 3 lymphopenia (%) | 28.5-43.9 % | · p.173 |
| Infections in Grade 4 lymphopenia | 18.8 % | Study APD334-301 · p.164 |
| Grade 2 lymphopenia (%) | 64-75.4 % | · p.173 |
| Grade 3 lymphopenia (%) | 1.3-2.1 % | · p.173 |
| Grade 3 TEAEs in Gastrointestinal disorders SOC (placebo) | 1.9 % | · p.155 |
Source: Pfizer Inc. ↗ · 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 →