Corticosteroid Therapy Granted Fast Track Designation for Pediatric Crohn's Disease
Soligenix announced that SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) has received Fast Track designation from the FDA for the induction treatment of mild-to-moderate pediatric Crohn's disease. SGX203 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. SGX203 is a two tablet delivery system (ie, immediate and delayed release) of BDP specifically designed for oral use that allows for delivery of BDP throughout the small bowel and the colon.
The FDA has previously awarded SGX203 Orphan Drug Designation for the treatment of pediatric Crohn's disease.
BDP has been marketed as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma.
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