Pfizer has received approval from the US Food and Drug Administration (FDA) for its VELSIPITY (etrasimod) to treat adult patients with moderately to severely active ulcerative colitis (UC).
VELSIPITY, an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator, is approved at a recommended dose of 2mg.
The approval from the FDA was based on data from the ELEVATE UC Phase III registrational programme, including ELEVATE UC 52 and ELEVATE UC 12.
These studies assessed the efficacy and safety of VELSIPITY 2mg once daily on clinical remission in UC patients who had earlier failed or were intolerant to a minimum of one conventional, biologic or Janus kinase (JAK) inhibitor therapy.
Almost two-thirds of patients in both trials were naïve to biologic or JAK inhibitor therapy.
With a favourable safety profile consistent with previous studies of VELSIPITY, the trials have also attained all primary and key secondary efficacy endpoints.
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In the ELEVATE UC 52 study, patients given VELSIPITY achieved a clinical remission rate of 27% at week 12, whereas those who received a placebo had a remission rate of 7%.
By week 52, the remission rates were 32% for the VELSIPITY group and 7% for the placebo group.
In the ELEVATE UC 12 trial, 26% of the patients who took VELSIPITY achieved clinical remission, while only 15% of those who received a placebo reached the same outcome.
Pfizer global biopharmaceuticals business president and chief commercial officer Angela Hwang stated: “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.”