The U.S. FDA’s Office of Orphan Products Development has granted orphan drug designation to Soligenix Inc.’s OrbeShield™ (oral BDP) as a measure to prevent death following a potentially lethal dose of total body irradiation during or after a radiation disaster.
Oral BDP, a highly potent, topically active corticosteroid, is the active ingredient in OrbeShield™, which is currently being developed for the treatment of gastrointestinal acute radiation syndrome (GI ARS), a leading cause of mortality following high doses of total body irradiation (TBI).
Orphan drug designation provides a seven-year term of market exclusivity for oral BDP upon final FDA approval, and positions Soligenix to leverage a wide range of financial and regulatory benefits, such as government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application for oral BDP, and certain tax credits.
“The FDA’s decision to grant oral BDP orphan drug designation signifies an important step for Soligenix as we continue to expand our oral BDP pipeline,” Christopher J. Schaber , PhD, president and CEO of Soligenix. “The marketing exclusivity that orphan drug designation imparts adds significantly to the existing patent estate surrounding OrbeShield™. We believe that OrbeShield™ has the potential to be a significant advancement in the preparation necessary for this nation to manage a public health emergency like a nuclear attack.”
For more information visit www.soligenix.com
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