FDA grants Soligenix Fast Track for OrbeShield for gastrointestinal acute radiation syndrome
Soligenix, a development-stage biopharmaceutical company, announced today that its OrbeShield (oral beclomethasone 17, 21-dipropionate or oral BDP) development program for the treatment of gastrointestinal acute radiation syndrome (GI ARS) has received Fast Track designation from the FDA.
Soligenix has also previously received Orphan Drug designation from the FDA for oral BDP for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.
"There are no FDA approved therapies for the treatment of GI ARS," said Christopher J. Schaber, PhD, president and CEO of Soligenix. "The FDA's action in granting Fast Track designation is a validation of BDP's potential to address this life-threatening, unmet medical need. We look forward to working closely with the FDA, as well as with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to potentially expedite the OrbeShield development program."