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news.DOR BioPharma has reported that the Office of Orphan Products Development of the FDA has granted orphan drug designation to Oral BDP for the treatment of pediatric Crohn's disease.
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The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven year term of market exclusivity for Oral BDP upon final FDA approval, orphan drug designation also positions DOR to be able to take advantage of a wide range of financial and regulatory benefits, including 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.
Oral BDP is said to be a highly potent, topically active corticosteroid that has a local effect on inflamed tissue.
Christopher Schaber, president and CEO of DOR BioPharma, said: “We anticipate that pediatric Crohn’s disease will be the first of several new orphan drug designations both in the US and in Europe as we work to maximize the global value of our Oral BDP and orBec franchise.”