European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis
19 Feb 2024
Clinical ResultDrug ApprovalPhase 3
NEW YORK, NY, USA I February 19, 2024 I 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
VELSIPITY is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory applications for VELSIPITY in ulcerative colitis have been submitted to additional countries including Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey, and the UK.
U.S. INDICATION
VELSIPITY is a selective sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of moderately to severely active UC in adults.
U.S. IMPORTANT SAFETY INFORMATION & INDICATION
Do not take VELSIPITY if you:
Talk to your healthcare provider before taking VELSIPITY if you have any of these conditions or do not know if you have any of these conditions.
VELSIPITY can cause serious side effects, including:
Before taking VELSIPITY, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using VELSIPITY with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:
You should not receive live vaccines at least 4 weeks before starting VELSIPITY, during treatment with VELSIPITY and for 5 weeks after you stop taking VELSIPITY. Talk to your healthcare provider before you receive a vaccine during treatment and for 5 weeks after treatment with VELSIPITY. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with VELSIPITY.
VELSIPITY can cause serious side effects, including:
The most common side effects of VELSIPITY include headache, elevated liver tests, and dizziness. These are not all of the possible side effects of VELSIPITY. For more information, ask your healthcare provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
INDICATION
VELSIPITY is a prescription medicine used to treat adults with moderately to severely active ulcerative colitis. It is not known if VELSIPITY is safe and effective in children.
About Pfizer: Breakthroughs that Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
References:
SOURCE: Pfizer
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