Policy & Regulation
Pfizer's VELSIPITY receives European Commission marketing authorisation to treat ulcerative colitis
22 February 2024 -

US-based pharmaceutical company Pfizer Inc. (NYSE: PFE), the partner of China-based Everest Medicines (HKEX 1952.HK), announced on Wednesday that it has received marketing authorisation from the European Commission (EC) for VELSIPITY (etrasimod) in the European Union.

The product, a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5, is intended 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.

The marketing authorisation for VELSIPITY is valid in all 27 EU member states and Iceland, Liechtenstein, and Norway. The approval was based on the outcome from the ELEVATE UC Phase three registrational program (ELEVATE UC 52 and ELEVATE UC 12) that assessed the safety and efficacy of VELSIPITY 2mg once-daily on clinical remission in UC subjects who had earlier failed or were intolerant to around one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Regulatory applications for VELSIPITY in ulcerative colitis have been submitted to additional countries including Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey and the UK.