Etrasimod (VELSIPITY®) Becomes First and Only Once-Daily Oral S1P Receptor Modulator Approved in the EU for Moderately to Severely Active Ulcerative Colitis in Patients Aged 16 and Older

On February 22, Everest Medicines' (HKEX 1952.HK) authorized partner, Pfizer Inc. (NYSE: PFE), announced that the European Commission has granted marketing authorization for Itrumod (VELSIPITY®) in the European Union for the treatment of patients aged 16 years and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional therapies or biologics.

Professor Wu Kaichun, the principal investigator of the etrasimod Asia-Pacific clinical trial, standing committee member of the World Gastroenterology Organization, vice chairman of the Digestive Disease Branch of the Chinese Medical Association, and affiliated with Xijing Hospital of the Fourth Military Medical University of the Chinese People's Liberation Army, stated: "The approval of etrasimod in Europe is another significant milestone. Etrasimod demonstrates a favorable benefit-risk profile. This next-generation S1P modulator, administered orally once daily, acts quickly to achieve steroid-free remission and mucosal healing, offering a new treatment option for adult patients with moderately to severely active ulcerative colitis. Patient recruitment for the Asia-Pacific clinical trial has been completed, and to date, the data shows positive top-line results during the 12-week induction phase. We look forward to its early approval in China and other Asian countries, benefiting more patients."

By 2030, the number of patients with ulcerative colitis in China is expected to more than double from 2019, reaching approximately 1 million people, indicating a significant unmet need for innovative therapies for this disease in the Chinese market.

The marketing authorization for Itrumod (VELSIPITY) covers all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Itrumod was previously approved by the U.S. Food and Drug Administration (FDA) in October 2023 for the treatment of adult patients with moderately to severely active ulcerative colitis, and in January 2024, it was approved in Canada for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapies or advanced therapeutic options.

This approval is based on the results of the ELEVATE UC Phase 3 registrational studies (ELEVATE UC 52 and ELEVATE UC 12), which evaluated the safety and efficacy of once-daily 2mg izumodrug in patients with ulcerative colitis who had previously failed or were intolerant to at least one conventional therapy, biologic, or JAK inhibitor. Additionally, ELEVATE UC 52 and ELEVATE UC 12 are the only advanced treatment studies in UC to include patients with isolated proctitis, a condition that affects approximately 30% of patients with ulcerative colitis. Both studies met all primary and key secondary efficacy endpoints and demonstrated a favorable safety profile consistent with previous izumodrug studies. Treatment with izumodrug also improved total scores on the Inflammatory Bowel Disease Questionnaire, which measures health-related quality of life. The most common adverse reactions were UC exacerbation (8%), anemia (8%), and headache (8%).

About Itrumod (VELSIPITY®)

Etrasimod (VELSIPITY) is an oral, once-daily selective sphingosine-1-phosphate (S1P) receptor modulator with optimized pharmacology design, binding to S1P receptors 1, 4, and 5. The new drug application for etrasimod (VELSIPITY) for the treatment of ulcerative colitis has been submitted in multiple countries, including Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey, and the United Kingdom.

Editor: Mu Mian

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