Everest Medicines  announced  that its licensing partner, Pfizer Inc. (NYSE: PFE) has received approval from the U.S. Food and Drug Administration (FDA) for VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). Importantly, VELSIPITY™'s label does not include the "titration is required for treatment initiation" language found in other S1P modulator's label. Everest is conducting a multi-center Phase 3 clinical trial of etrasimod in Asia and aims to file New Drug Application as soon as possible.

"We congratulate our partner for achieving this significant milestone for UC patients who are in urgent need of new and effective treatment options, and prefer the convenience of a once-daily pill. Etrasimod is a proven advanced treatment with a favorable safety profile." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Everest will advance our late-stage study as quickly as possible towards registration in China and other Asian markets as the incidence of ulcerative colitis has been rapidly increasing in the region in recent years."

"Etrasimod's FDA approval marks an important milestone for moderately to severely active UC patients who need new treatments for this chronic condition. Etrasimod provides those patients with the treatment option of an oral, once-daily pill that has a favorable benefit-risk profile," said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod's clinical trial in Asia. "The Asia Phase 3 clinical trial has completed patient enrollment and we look forward to having etrasimod available in China and other Asian countries to benefit more patients."

The number of UC patients in China is expected to more than double from 2019 to reach approximately one million by 2030, highlighting the need for novel treatments for the disease. Etrasimod was developed by Arena Pharmaceuticals, which was acquired by Pfizer in 2022. Everest Medicines obtained exclusive rights from Arena to develop, manufacture and commercialize etrasimod in Greater China and South Korea in 2017.

The U.S. FDA approval was based on 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. Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis to include patients with isolated proctitis. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.

In ELEVATE UC 52, clinical remission was 27.0% for patients receiving etrasimod compared to 7.0% for patients receiving placebo at week 12 (20.0% differential, P˂.001) and was 32.0% compared to 7.0% at week 52 (26.0% differential, P=˂.001). In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving etrasimod compared to 15.0% of patients receiving placebo (11.0% differential, P=<.05). All key secondary efficacy endpoints were met at week 12, including endoscopic improvement and mucosal healing. The safety of etrasimod was consistent with previous studies, with the most common adverse reactions being headache, elevated liver tests, and dizziness (incidence ≥ 5%).