FDA approves orphan drug status for Dusquetide for Macrophage Activation Syndrome

Release Date: 17-Nov-2016

Soligenix Inc., a pharmaceutical company, specialized in developing and commercializing medicines to treat rare diseases declared that Food and Drug association (FDA) has granted its leading candidate, Dusquetide, orphan drug designation for the treatment of patients with Macrophage Activation Syndrome (MAS). Perviously, Dusquetide was granted orphan drug status for treatment of Acute Radiation Syndrome (ARS).

Dusquetide is an innate defense regulator (IDR) belonging to a new class of short, synthetic peptides that accelerates bacterial clearance and resolution of tissue damage while modulating inflammation following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy.   

Orphan Drug designation is granted by the FDA's Office of Orphan Products Development for drugs that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually. Orphan Drug designation qualifies a company for several benefits under the Orphan Drug Act 1983. These benefits include assistance with clinical study design in drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

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