The US FDA has granted Soligenix fast track designation for OrbeShield for the reduction of mortality associated with gastrointestinal acute radiation syndrome (GI ARS).
The oral beclomethasone 17,21-dipropionate (oral BDP) earlier received FDA orphan drug designation for the prevention of death after a high or lethal body irradiation dose during or subsequent to a radiation disaster.
Soligenix president and chief executive officer Christopher Schaber said the FDA fast track designation validates BDP's potential to address the unmet medical need of GI ARS.
"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," Schaber added.
