US EditionFDA Grants Orphan Drug Designation to Dusquetide for Behçet’s Disease
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FDA grants orphan drug status to Soligenix’s dusquetide
This designation comes after the FDA Office of Orphan Products Development reviewed recent Phase IIa clinical trial results, which showed both biological efficacy and safety in patients with The post FDA grants orphan drug status to Soligenix’s dusquetide appeared first on Pharmaceutical Business review.
Istanbul – Between 4% and 26% of people with Behçet's disease develop the disease in childhood. A multicenter study in 19 clinical centers from six countries now shows that adalimumab and infliximab are effective in this age group. In a Turkish and a European cohort, the majority of children were at the end of...
Soligenix receives orphan drug designation for treatment of Behçet's disease - BioTuesdays
Soligenix (NASDAQ: SNGX) has announced that the FDA has granted orphan drug designation to dusquetide—the active ingredient in SGX945—for the treatment of Behçet’s disease, upon review of Phase 2 trial results. According to Soligenix, in addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions the company to be able to leverage a wide range of financial and regulatory benefits,…
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