Pfizer: FDA, EMA eye Submissions for Ulcerative Colitis

 Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for etrasimod for individuals living with moderately-to-severely active ulcerative colitis (UC). The FDA’s decision is expected in the second half of 2023. 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.

Etrasimod is an oral, once daily, selective sphingosine-1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5. In addition to UC, it is being investigated for a range of other immuno-inflammatory diseases.

UC is a chronic and often debilitating condition1 that affects an estimated 3.8 million people in North America and Europe.2 Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain, and urgency.3,4 UC can have a significant effect on work, family, and social activities. There is a need for additional advanced therapeutic options in UC that are oral, effective, and have a favorable risk-benefit profile.

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