Everest Medicines and licensing partner Pfizer receive FDA and EMA approval for ulcerative colitis drug

Everest Medicines, a biopharmaceutical company, has announced that its licensing partner, Pfizer, has received acceptance from the FDA for a New Drug Application (NDA), and from the European Medicines Agency (EMA) for the Marketing Authorisation Application (MAA) for etrasimod

Etrasimod is used for people living with moderate-to-severely active ulcerative colitis (UC). It is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator.

It was originally developed by Arena Pharmaceuticals, who were acquired by Pfizer last year, and Everest Medicines obtained the exclusive rights from Arena Pharmaceuticals to develop, manufacture and commercialise etrasimod in Greater China and South Korea in 2017.

The number of UC patients in China is expected to reach over 900,000 by 2030, and at the moment there is a significant unmet need for novel treatments for the disease.

Pfizer’s NDA submissions were based on results from the ELEVATE UC phase 3 trials (ELEVATE UC 52 and ELEVATE UC 12), which evaluated the safety and efficacy of estrasimod 2mg once daily for patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.

In both randomised, double blind, placebo-controlled studies, all primary and key secondary endpoints were achieved, with a safety profile consistent with previous studies.

Rogers Yongqing Luo, chief executive officer of Everest Medicines commented, “We congratulate our partner for making important regulatory advancements towards bringing etrasimod as a potentially best-in-class therapy to ulcerative colitis patients. We aim to complete patient enrolment 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.”

James Spargo