Pfizer Inc. — Velsipity FDA Review (NDA216956, ORIG 1, 2023)
Pfizer Inc. · 2023 · FDA Review (openFDA) · company profile →
Report summary
Pfizer's New Drug Application for Velsipity (etrasimod) for moderately to severely active ulcerative colitis in adults is recommended for approval based on a multi-disciplinary review. Two Phase 3 trials (APD334-301 and APD334-302) demonstrated Velsipity's efficacy in achieving clinical remission and an acceptable safety profile, consistent with other S1P receptor modulators. The proposed 2 mg daily oral dosage is supported by clinical pharmacology data. While toxicology studies revealed developmental toxicity in rats and rabbits, carcinogenicity in mice (hemangiosarcoma), and a mutagenic process-related impurity, these findings are balanced against the clinical benefits. Safety data from trials indicated a higher incidence of treatment-emergent adverse events, including cardiovascular events, infections, and liver injury, but most were mild. Warnings and precautions for these risks will be included in the label. Overall, the benefits of etrasimod are deemed to outweigh the risks for the target patient population.
Key findings — cited to the page
| Review Completion Date | October 12, 2023 | Velsipity (etrasimod) · p.2 |
| Recommended Indication | Treatment of moderately to severely active ulcerative colitis in adults | Velsipity (etrasimod) · p.2 |
| Carcinogenicity (hemangiosarcoma malignant tumor and combined hemangioma/hemangiosarcoma) incidence in mice at 20 mg/kg/day | statistically significant increase | Etrasimod (APD334 L-arginine) · p.312 |
| PDUFA Goal Date | October 14, 2023 | Velsipity (etrasimod) · p.2 |
| Proposed Indication | Treatment of moderately to severely active ulcerative colitis in adults | Velsipity (etrasimod) · p.2 |
| Regulatory Action Recommendation | Approval | Velsipity (etrasimod) · p.2 |
| Carcinogenicity (hemangiosarcoma malignant tumor and combined hemangioma/hemangiosarcoma) | positive | Etrasimod (APD334 L-arginine) · p.312 |
| Carcinogenicity (hemangiosarcoma malignant tumor and combined hemangioma/hemangiosarcoma) incidence in mice at 6 mg/kg/day | statistically significant increase | Etrasimod (APD334 L-arginine) · p.312 |
| Carcinogenicity (hemangiosarcoma malignant tumor and combined hemangioma/hemangiosarcoma) in rats | negative | Etrasimod (APD334 L-arginine) · p.312 |
| Application Number | 216956 | Velsipity (etrasimod) · p.2 |
| NDA Number | 216956 | Velsipity (etrasimod) · p.11 |
| Recommended Dosing Regimen | 2 mg taken orally once daily | Velsipity (etrasimod) · p.2 |
Source: Pfizer Inc. ↗ · 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 →