Nov. 8, 2012
/PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that its program for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of mild-to-moderate pediatric Crohn's disease has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Soligenix has also previously received Orphan Drug Designation from the FDA for oral BDP as a treatment for pediatric Crohn's Disease.
Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX203 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which implies an abbreviated review time of six months.
"There are no FDA approved corticosteroid therapies for the induction treatment of Crohn's disease in the pediatric population," stated
Christopher J. Schaber
, PhD, President & Chief Executive Officer of Soligenix. "The FDA's action in granting fast track designation is an indication of SGX203's potential to address this debilitating, unmet medical need. We look forward to working closely with the FDA to potentially expedite the development and NDA review process."
About Pediatric Crohn's Disease
Crohn's disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. Crohn's disease can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine, called the ileum. The swelling caused by the disease extends deep into the lining of the affected organ. The swelling can induce pain and can make the intestines empty frequently, resulting in diarrhea. Because the symptoms of Crohn's disease are similar to other intestinal disorders, such as irritable bowel syndrome and ulcerative colitis, it can be difficult to diagnose. People of Ashkenazy Jewish heritage have an increased risk of developing Crohn's disease.