The Food and Drug Administration (FDA) has granted Orphan Drug designation to etrasimod for the treatment of eosinophilic esophagitis.
Etrasimod is an investigational highly selective sphingosine 1-phosphate receptor modulator. The product is designed to partially and reversibly reduce lymphocyte levels at sites of inflammation, while maintaining components of immune function.
The Company is evaluating the efficacy and safety of etrasimod in the randomized, double-blind, placebo-controlled phase 2b VOYAGE trial (ClinicalTrials.gov Identifier: NCT04682639) in adults with eosinophilic esophagitis. Etrasimod is also being investigated for the treatment of immune-mediated inflammatory diseases including ulcerative colitis, Crohn disease, atopic dermatitis, and alopecia areata.
The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals.
Arena Pharmaceuticals announces Orphan Drug designation for etrasimod for the treatment of eosinophilic esophagitis (EoE). [press release]. Park City, Utah: Arena Pharmaceuticals, Inc.; June 9, 2021.