Soligenix Inc. (SNGX) on Thursday said that the European Medicines Agency's Committee for Orphan Medicinal Products has issued a positive recommendation on the company's request for orphan drug designation for dusquetide (the active pharmaceutical ingredient in SGX945) to treat Behçet's disease.
The recommendation follows review of Phase 2a clinical data showing the biological efficacy and safety of dusquetide, the active ingredient in SGX945, in patients with the condition. The next step is ratification of the designation by the European Commission.
If granted, orphan drug status would provide up to 10 years of market exclusivity in the European Union after product approval, along with development incentives and regulatory support.
SGX945 has already received orphan drug and fast-track designations from the U.S. Food and Drug Administration for the treatment of Behçet's disease.
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