The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for etrasimod for the treatment of patients with moderately to severely active ulcerative colitis (UC).
Etrasimod is an oral selective sphingosine 1-phosphate (S1P) receptor modulator currently being investigated to treat a range of immuno-inflammatory diseases.
The NDA is supported by data from 2 multicenter, randomized, placebo-controlled phase 3 trials, ELEVATE UC 52 (ClinicalTrials.gov Identifier: NCT03945188) and ELEVATE UC 12 (ClinicalTrials.gov Identifier: NCT03996369). Both trials evaluated the efficacy and safety of etrasimod 2mg once daily vs placebo in patients with UC who had previously failed or were intolerant to at least 1 conventional, biologic, or Janus kinase (JAK) inhibitor therapy. The primary endpoint was clinical remission based on the modified Mayo score (MMS) at week 12.
Results from the ELEVATE UC 52 study showed that 27% of patients treated with etrasimod achieved clinical remission at week 12 compared with 7.4% of those treated with placebo (19.8% differential; P =.001). Clinical remission was also achieved among 32.1% of patients treated with etrasimod at week 52 compared with 6.7% of those treated with placebo (25.4% differential; P =.001).
In the ELEVATE UC 12 study, 24.8% of patients treated with etrasimod achieved clinical remission compared with 15.2% of those treated with placebo (9.7% differential; P =.0264). Both studies met all key secondary endpoints including endoscopic improvement, symptomatic remission, and mucosal healing.
As for safety, the most common treatment-emergent adverse events (incidence of at least 3% of etrasimod-treated patients and greater than placebo) for etrasimod were headache, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea. There were no reports of bradycardia or atrioventricular block.
The FDA is expected to make a decision in the second half of 2023.
“Ulcerative colitis can substantially impact the day-to-day lives of people living with this chronic and often debilitating disease, and many patients never achieve nor maintain remission on today’s therapies,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “We believe that etrasimod, if approved, has the potential to be a best-in-class, first-line advanced therapy for people living with moderately-to-severely active ulcerative colitis, based on its clinical profile.”
- Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis. News release. Pfizer. Accessed December 21, 2022. https://www.businesswire.com/news/home/20230104005006/en/Pfizer-Announces-FDA-and-EMA-Acceptance-of-Etrasimod-Regulatory-Submissions-for-Ulcerative-Colitis.
- Pfizer presents ELEVATE pivotal findings demonstrating etrasimod’s potentially best-in-class profile in ulcerative colitis. News release. Pfizer. May 24, 2022. Accessed December 21, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-presents-elevate-pivotal-findings-demonstrating.