Velsipity is an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator, approved by the US FDA to treat moderately to severely active ulcerative colitis (UC), based on results from the Phase 3 ELEVATE UC registrational programme
New Pfizer headquarters entrance. (Credit: Pfizer Inc.)
Pfizer has received the US Food and Drug Administration (FDA) approval for Velsipity (etrasimod), to treat adults with moderately to severely active ulcerative colitis (UC).
Velsipity is an oral, once-daily, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5.
The US health regulator approved the drug based on results from the Phase 3 ELEVATE UC registrational programme which includes ELEVATE UC 52 and ELEVATE UC 12 studies.
The studies evaluated the safety and efficacy of Velsipity 2mg in UC patients who previously failed or were intolerant to at least one conventional, biologic, or JAK-inhibitor therapy.
Pfizer submitted regulatory applications for Velsipity in ulcerative colitis to regulatory authorities in several countries, including Canada, Australia, Mexico, Russia, Switzerland, and Singapore.
The European Medicines Agency (EMA) has accepted the company’s Marketing Authorization Application (MAA) for Velsipity, with a decision expected at the beginning of 2024.
Pfizer chief commercial officer and global biopharmaceuticals business president Angela Hwang said: “Velsipity provides adults living with moderately to severely active UC the opportunity to achieve steroid-free remission with an oral, once-daily pill that has a favourable benefit-risk profile.
“Velsipity’s FDA approval today marks a significant milestone for UC patients who need new treatments for this chronic condition and are ready to start advanced therapy.”
UC is a chronic and often serious condition, characterised by chronic diarrhoea with blood and mucus, abdominal pain, and urgency, and impacts the physical and other aspects of life.
ELEVATE UC 52 is a randomized, double-blind, placebo-controlled trial that uses a treat-through design comprising a 12-week induction period and a 40-week maintenance period.
ELEVATE UC 12 is a randomized, double-blind, placebo-controlled trial that evaluates the efficacy and safety of etrasimod 2mg in subjects with moderately to severely active UC.
Both studies achieved all primary and key secondary efficacy endpoints, with a positive safety profile that is consistent with previous studies of Velsipity.
Around two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12, respectively, were naïve to biologic or JAK inhibitor therapy, said Pfizer.
In a separate development, Pfizer has amended its supply agreement with the US government for Paxlovid (nirmatrelvir/ritonavir), its FDA-approved co-packaged oral antiviral medication.
In addition, Pfizer will manage and supply the US Strategic National Stockpile (SNS) comprising one million courses to support future pandemic preparedness.