FDA Approves Pfizer's Oral Ulcerative Colitis Drug VELSIPITY
The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc.'s VELSIPITY™ (etrasimod) for adults with moderately to severely active ulcerative colitis (UC). The oral medication is administered once daily.
Pfizer Inc. announced its VELSIPITY™ (etrasimod) has received approval from the U.S. Food and Drug Administration (FDA). The oral, once-daily medication is indicated for adult patients experiencing moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease.
Ulcerative colitis affects an estimated 1.25 million people in the United States, characterized by symptoms such as chronic diarrhea, abdominal pain, and urgency. The FDA's decision was based on data from the ELEVATE UC Phase 3 clinical trial program. These trials evaluated the safety and efficacy of VELSIPITY 2 mg in patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
The ELEVATE UC 52 trial demonstrated that 27.0% of patients receiving VELSIPITY achieved clinical remission at week 12, compared to 7.0% on placebo. At week 52, remission rates were 32.0% for VELSIPITY compared to 7.0% for placebo. The ELEVATE UC 12 trial also met its primary endpoint with 26.0% of patients on VELSIPITY achieving remission versus 15.0% on placebo at week 12. Key secondary endpoints, including endoscopic improvement, were also met.
The safety profile of VELSIPITY was consistent with previous studies, with the most common adverse reactions reported as headache, elevated liver tests, and dizziness. Pfizer has submitted regulatory applications for VELSIPITY in ulcerative colitis in other countries globally.