Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
“For the 2.6 million people in Europe living with UC, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating. They may cycle through several different conventional treatment options to find relief for their symptoms,” said Séverine Vermeire, MD, PhD, Professor of Medicine at KU Leuven and an investigator in the ELEVATE Registrational Program. “The approval of VELSIPITY helps bridge the gap for those with moderately to severely active UC who need an effective advanced treatment but may be apprehensive about using injectable therapies like biologics.” The marketing authorization for VELSIPITY is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023. It also follows VELSIPITY’s approval for adults with moderately to severely active UC by the U.S. Food and Drug Administration (FDA) in October 2023, and for adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or an advanced treatment in Canada in January 2024. Regulatory applications for VELSIPITY in UC have been submitted to additional countries around the world for review.
“VELSIPITY can help appropriate patients with UC who are struggling to achieve remission on conventional therapies,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With convenient, once-daily oral dosing and a favorable benefit-risk profile, VELSIPITY is an attractive potential treatment option and Pfizer is proud to bring this medicine to appropriate UC patients as young as 16 years old in the European Union.” The approval was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) 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.
Additionally, ELEVATE UC 52 and ELEVATE UC 12 were the only studies of advanced therapies for UC to include patients with isolated proctitis, which affects approximately 30% of those diagnosed with UC. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY. VELSIPITY also demonstrated improvement in the total inflammatory bowel disease questionnaire score, which measures health-related quality of life. The most common adverse reactions were lymphopenia (11%) and headache (7%).
About Ulcerative Colitis
UC is a chronic, immune-mediated inflammatory bowel disease characterized by diffuse mucosal inflammation.1 Clinical symptoms of UC may include but are not limited to frequent diarrhea, bowel urgency, rectal bleeding, abdominal pain, fatigue, fever and anemia.2,3,4 Its impact can span beyond the physical to other aspects of life due to the chronic and unpredictable nature of symptoms.5,6
References:
1. Ungaro R, et al. Ulcerative colitis. Lancet. 2017;389(10080):1756-70
2. Seyedian SS, et al. A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease. J Med Life. 2019;12(2):113-122.
3. Dubinsky MC, et al. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022;4(3):otac016.
4. Grimstad T, et al. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015;9(9):7
5. Armuzzi A, et al. The Association between Disease Activity and Patient-Reported Outcomes in Patients with Moderate-To-Severe Ulcerative Colitis in the United States and Europe. BMC Gastroenterol. 2020;20(1):18.
6. Ordás I, et al. Ulcerative Colitis. Lancet. 2012;380(9853):1606-19.