Omeros Gets Orphan Drug Designation for OMS721

Omeros said that its experimental immunotherapy, OMS721, has received orphan drug designation from the US Food and Drug Administration for the treatment of Immunoglobulin A (IgA) kidney disease. Phase 2 clinical trial results with OMS721 in IgA kidney disease patients showed unprecedented reductions in urine protein levels during and following treatment with OMS721, as the company previously reported.

FDA grants orphan designation to promote the development of a drug that is expected to have significant therapeutic advantage over existing treatments that target a condition affecting 200,000 or fewer US patients annually, Omeros said. It qualifies a company for benefits that apply across all stages of drug development, including seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees, it said.

By Caroline Williams