FDA批准伊曲莫德(Etrasimod)用于患有中度至重度活动性溃疡性结肠炎的成人

Etrasimod is a sphingosine-1-phosphate (S1P) receptor modulator, developed by Pfizer of the United States. It was approved for marketing by the U.S. Food and Drug Administration (FDA) on October 12, 2023. This approval applies to all 27 EU member states, as well as Iceland, Liechtenstein and Norway.

Etrasimod FDA-approved indication

Ulcerative colitis

Etrasimod is approved for adult patients with moderately to severely active ulcerative colitis (UC). The approval of Etrasimod was based on the results of the ELEVATEUC Phase 3 registration program (ELEVATEUC52 and ELEVATEUC12).

About Ulcerative Colitis

Ulcerative colitis is a chronic and often debilitating disease1 that affects an estimated 1.25 million people in the United States. Symptoms of ulcerative colitis may include chronic diarrhea with blood and mucus, abdominal pain, and urgency to urinate. However, due to the chronic and unpredictable nature of symptoms, its effects may extend beyond the physical body into other aspects of life.

About ELEVATEUC52 and ELEVATEUC12

ELEVATEUC52 and ELEVATEUC12 are pivotal trials that are part of the ELEVATEUC Phase 3 registration program:

1. ELEVATEUC52

ELEVATEUC52 is a randomized, double-blind, placebo-controlled trial with a treatment design that includes a 12-week induction phase and a 40-week maintenance phase. Subjects were randomly assigned to the Velsipity or placebo group and continued treatment throughout the study without rerandomization. Beginning at week 12, all patients can continue randomized treatment; patients whose disease does not improve or worsen compared with baseline can discontinue treatment and, if eligible, enroll in an open-label extension study.

2. ELEVATEUC12

ELEVATEUC12 is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of etridolimod 2 mg once daily in subjects with moderately to severely active UC. The primary objective of the trial is to evaluate the safety and efficacy of etridolimod in clinical response as assessed by FDA-required 3-domain MMS at 12 weeks.