The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with the decision anticipated in the first half of 2024. The anticipated U.S. FDA approval will be the first approval of etrasimod globally.

"We congratulate our partner for making important regulatory advancements towards bringing etrasimod as a potentially best-in-class therapy to ulcerative colitis patients," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We aim to complete patient enrollment for our phase 3 study in Asia in the first half of 2023 and, if approved, hope to bring this novel treatment to Asian population as soon as possible."

Etrasimod was developed by Arena Pharmaceuticals, which was acquired by Pfizer earlier this year. Everest Medicines obtained exclusive rights from Arena to develop, manufacture and commercialize etrasimod in Greater China and South Korea in 2017. The incidence of UC is increasing continuously in China in the recent decades. The number of UC patients in China is expected to more than double from 2019 to reach over 900,000 by 2030 highlighting significant unmet demand for novel treatment for the disease. According to the Frost & Sullivan report, the market size of UC was RMB3.4 billion in 2019 in China and is estimated to expand to RMB8.1 billion by 2024, representing compound annual growth rate of 18.9%.

Pfizer's NDA submissions were based on previously announced results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Both randomized, double-blind, placebo-controlled studies achieved all primary and key secondary endpoints, with a safety profile consistent with previous studies. In the ELEVATE UC 52 study, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P≤.001) and was 32.1% compared to 6.7% at week 52 (25.4% differential, P≤.001). In ELEVATE UC 12, clinical remission was achieved among 24.8% of patients receiving etrasimod compared to 15.2% of patients receiving placebo (9.7% differential, P=.0264).