Soligenix’s SGX945 granted European Orphan Drug Designation in Behcet’s Disease

Soligenix (SNGX) announced that the European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, has granted orphan drug designation to dusquetide, the active pharmaceutical ingredient in SGX945, for the treatment of Behcet’s Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behcet’s Disease. SGX945 has previously been granted both orphan drug and fast track designations from the FDA for the treatment of Behcet’s Disease. Orphan drug designation by the EMA provides a 10-year period of marketing exclusivity in the EU after product approval. Orphan designation also provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.