“Ulcerative colitis can substantially impact the day-to-day lives of people living with this chronic and often debilitating disease, and many patients never achieve nor maintain remission on today’s therapies,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. There is a need for additional advanced therapeutic options in UC that are oral, effective, and have a favorable risk-benefit profile. 3,4 UC can have a significant effect on work, family, and social activities. 2 Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain, and urgency. UC is a chronic and often debilitating condition 1 that affects an estimated 3.8 million people in North America and Europe.
In addition to UC, it is being investigated for a range of other immuno-inflammatory diseases. 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.Įtrasimod 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. The FDA’s decision is expected in the second half of 2023. 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). (NYSE: PFE) announced today that the U.S. Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile consistent with previous studies
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