- The FDA has granted Orphan Drug Designation status to Arena Pharmaceuticals' (ARNA) etrasimod, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator, for the treatment of eosinophilic esophagitis (EoE), a chronic, allergic inflammatory disease of the esophagus.
- Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
- Etrasimod is being investigated in the Phase 2b VOYAGE trial, with a primary efficacy measurement at week 16 and a secondary efficacy analysis at week 24, to assess the safety and efficacy of 1 mg and 2 mg etrasimod in ~100 participants.