Soligenix Receives Positive EMA Orphan Drug Opinion for Dusquetide in Behçet Disease Treatment

The European Medicines Agency Committee for Orphan Medicinal Products has issued a positive recommendation for orphan drug designation of dusquetide, the active ingredient in SGX945, for the treatment of Behçet Disease. This recommendation follows review of recently published Phase 2a data demonstrating biological efficacy and safety, and now advances to the European Commission for ratification.

Orphan designation in the European Union provides 10 years of market exclusivity upon approval, along with development incentives and centralized authorization access. This regulatory milestone represents significant progress for patients with Behçet Disease, a rare inflammatory disorder characterized by recurrent oral and genital ulcers, skin lesions, and potential systemic complications affecting multiple organ systems.

SGX945 has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration for Behçet Disease, indicating recognition of the treatment’s potential to address unmet medical needs in this rare disease population. The company’s development programs include expansion of synthetic hypericin into psoriasis and dusquetide for treatment of inflammatory diseases, including oral mucositis in head and neck cancer.

Soligenix’s broader portfolio includes development programs for RiVax, a ricin toxin vaccine candidate, and vaccine programs targeting filoviruses such as Marburg and Ebola, as well as CiVax for prevention of COVID-19. These programs incorporate the company’s proprietary heat stabilization platform technology known as ThermoVax and have been supported with government grant and contract funding from agencies including the National Institute of Allergy and Infectious Diseases.

The latest news and updates relating to Soligenix are available through the company’s communications platform, which provides specialized coverage of developments in biotechnology and biomedical sciences. This positive EMA opinion represents a critical step toward potential European market authorization and improved treatment options for patients suffering from Behçet Disease, a condition with limited therapeutic alternatives currently available.

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