Velsipity(etrasimod)

Velsipity (etrasimod) is a new active substance proposed for the treatment of moderately to severely active ulcerative colitis in adults, with a proposed daily dose of 2 mg. The drug is indicated for individuals 16 years of age and older. The FDA review for Velsipity (NDA216956) was completed on October 12, 2023, with a PDUFA Goal Date of October 14, 2023.

Efficacy findings from regulatory reviews include a mean difference from placebo in adapted MCS of -0.99. Rates of patients achieving clinical remission (3-component) ranged from 8.1% to 33.0%. Mucosal healing was observed in 21.2% of patients, while histological healing was observed in 10.2% to 31.7% of patients. Symptomatic remission rates ranged from 24.1% to 38.7%, with complete symptomatic remission (RB=0, SF=0) observed in 1.8% to 4.5% of patients.

Regarding safety, carcinogenicity studies showed a positive finding for hemangiosarcoma malignant tumor and combined hemangioma/hemangiosarcoma in mice, with statistically significant increases in incidence at 6 mg/kg/day and 20 mg/kg/day. However, carcinogenicity in rats was negative. The overall safety profile was deemed acceptable. A total of 132 subjects were treated with etrasimod 2 mg for 52 weeks, compared to 40 subjects on placebo for the same duration.