US FDA Grants Orphan Drug Designation For Etrasimod To Treat Eosinophilic Esophagitis Eoe

Release Date: 09-Sep-2021

U.S. FDA has granted Orphan Drug Designation status to etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator, for the treatment of eosinophilic esophagitis (EOE).Etrasimod (APD334) is discovered by Arena Pharmaceuticals Company and designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5, which may lead to an improved efficacy and safety profile. Etrasimod is intended to provide systemic and local effects on specific immune cell types. It has the potential to treat several immune-mediated inflammatory diseases including eosinophilic esophagitis, atopic dermatitis, ulcerative colitis, Crohn’s disease, and alopecia areata.


Etrasimod is being investigated in the Phase 2b VOYAGE trial, a randomized, double-blind, placebo-controlled trial, with an initial efficacy measurement at week 16 and a secondary efficacy measurement at week 24, to assess the safety and efficacy of 1 mg and 2 mg etrasimod in around 100 participants with EoE. Etrasimod is an investigational compound which has not got approved for any use in any country.

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