FDA accepts for review Pfizer’s NDA for etrasimod

Pfizer announced that the FDA has accepted for review a New Drug Application, or NDA, for etrasimod for individuals living with moderately-to-severely active ulcerative colitis, or UC. The FDA’s decision is expected in the second half of 2023. The European Medicines Agency, or EMA, has also accepted the Marketing Authorization Application, or 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, or 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.