Pfizer Inc. has announced that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union, marking a significant advancement in the treatment landscape for patients aged 16 and above with moderately to severely active ulcerative colitis (UC). This approval signifies a milestone as VELSIPITY becomes the first and only oral advanced therapy approved for this patient population in the EU.

Dr. Séverine Vermeire, Professor of Medicine at KU Leuven and an investigator in the ELEVATE Registrational Program, highlighted the challenges faced by the 2.6 million individuals in Europe living with UC, emphasizing the debilitating physical, mental, and emotional toll of the condition. She stressed the importance of bridging the treatment gap for patients who require effective advanced therapy but may harbor concerns regarding injectable biologics.

The marketing authorization for VELSIPITY covers all 27 EU member states, along with Iceland, Liechtenstein, and Norway. This regulatory green light follows the positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023. It aligns with previous approvals granted by the U.S. Food and Drug Administration (FDA) in October 2023 and by Canadian authorities in January 2024.

Alexandre de Germay, Pfizer's Chief International Commercial Officer, highlighted VELSIPITY's potential to address the unmet needs of UC patients who struggle to achieve remission with conventional therapies. He emphasized the convenience of once-daily oral dosing and the favorable benefit-risk profile of VELSIPITY, underscoring Pfizer's commitment to providing a viable treatment option for UC patients as young as 16 years old across the European Union.

The approval of VELSIPITY is grounded in data from the ELEVATE UC Phase 3 registrational program, comprising ELEVATE UC 52 and ELEVATE UC 12 studies. These trials assessed the safety and efficacy of VELSIPITY 2 mg once-daily in UC patients who had previously failed or were intolerant to conventional, biologic, or Janus kinase (JAK) inhibitor therapies. Notably, the studies included patients with isolated proctitis, a subgroup often overlooked in clinical trials. VELSIPITY demonstrated positive outcomes on primary and key secondary efficacy endpoints, alongside a favorable safety profile consistent with earlier studies.

The most common adverse reactions observed were lymphopenia (11%) and headache (7%). The approval of VELSIPITY heralds a new era in the management of UC, offering hope to patients and healthcare providers alike, and reaffirming Pfizer's commitment to advancing treatments in gastroenterology.

This groundbreaking approval sets a precedent in the realm of ulcerative colitis management, ushering in a new era of oral advanced therapy and empowering patients with a novel treatment option to reclaim control over their lives