Velsipity FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 13, 2023.
FDA Approved: Yes (First approved October 12, 2023)
Brand name: Velsipity
Generic name: etrasimod
Dosage form: Tablets
Company: Pfizer Inc.
Treatment for: Ulcerative Colitis
Velsipity (etrasimod) is a sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of moderately-to-severely active ulcerative colitis (UC) in adults.
- Ulcerative colitis is a chronic inflammatory bowel disease characterized by diarrhea, abdominal pain, and weight loss.
- Velsipity contains etrasimod, a selective sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1, 4, and 5, while avoiding subtypes 2 and 3. Selective binding with S1P receptor subtype 1 is believed to inhibit a specific subset of activated lymphocytes from migrating to sites of inflammation. The exact way in which etrasimod works in the treatment of ulcerative colitis is unknown, but it is thought to involve the reduction of lymphocyte migration into the intestines.
- FDA approval of Velsipity was based on favorable results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12 randomized, double-blind, placebo-controlled trials) that evaluated the safety and efficacy of Velsipity 2 mg once-daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy (nearly two-thirds of the patients in the studies were naïve to biologic or JAK inhibitor therapy). In ELEVATE UC 52, clinical remission was 27.0% for patients receiving Velsipity compared to 7.0% for patients receiving placebo at week 12, and was 32.0% compared to 7.0% at week 52. In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving Velsipity compared to 15.0% of patients receiving placebo.
- Velsipity tablets are administered orally, once daily.
- Warnings and precautions associated with Velsipity include increased risk of infections, bradyarrhythmia and atrioventricular conduction delays, liver injury, increased risk of macular edema, increased blood pressure, fetal harm, malignancies (including skin malignancies), posterior reversible encephalopathy syndrome (PRES), decline in pulmonary function, unintended additive immune system effects from prior treatment with immunosuppressive or immune-modulating drugs, and immune system effects for up to 5 weeks after the last dose.
- Common adverse reactions include headache, elevated liver tests, and dizziness.
- In addition to ulcerative colitis, etrasimod is being investigated for a range of other immuno-inflammatory diseases, including Crohn’s disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata.
Development timeline for Velsipity
Further information
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