Soligenix said the European Commission has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for the treatment of Behçet’s disease after reviewing positive Phase 2a data showing biological efficacy and safety in patients. SGX945 already holds orphan drug and fast track status with the U.S. Food and Drug Administration for Behçet’s disease, a rare, incurable autoimmune condition that affects an estimated 50,000 people in Europe and up to 1 million worldwide.
The EMA orphan designation provides 10 years of market exclusivity in the European Union following approval, along with incentives such as protocol assistance and access to the centralized marketing authorization procedure for products targeting serious conditions with limited treatment options. Soligenix President and CEO Christopher J. Schaber said the decision is an important step for the SGX945 program and underscores the potential of dusquetide to address oral aphthous ulcers and other manifestations in a population with significant unmet medical need.
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