Meanwhile across the pond, Soligenix receives EU orphan drug status for Behçet’s disease treatment

Soligenix Inc. (NASDAQ: SNGX) announced that the European Commission granted orphan drug designation to dusquetide, the active ingredient in SGX945, for treating Behçet’s Disease. The designation followed a positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products after reviewing published Phase 2a clinical results.

The European orphan drug designation provides 10 years of marketing exclusivity in the European Union after product approval. It also offers incentives for protocol assistance during development and direct access to centralized authorization procedures. The European Commission grants orphan designations for medicines treating life-threatening or chronically debilitating conditions affecting no more than five in 10,000 persons in the EU where no satisfactory treatment exists.

SGX945 previously received orphan drug and fast track designations from the U.S. Food and Drug Administration for Behçet’s Disease treatment. The drug also received Promising Innovative Medicine designation from the UK’s Medicines and Healthcare Products Regulatory Agency.