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news.Dor BioPharma, a R&D biopharmaceutical company, has announced that its program for the development of DOR201 for the prevention of acute radiation enteritis has received fast track designation from the FDA.
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For instance, should events warrant, Dor will be eligible to submit a new drug application (NDA) for DOR201 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.
Christopher Schaber, president and CEO of Dor, said: “There are no FDA approved therapies to prevent acute radiation enteritis. The FDA’s action in granting fast track designation is an indication of DOR201’s potential to address this serious, unmet medical need with over 100,000 patients at risk annually.
“As the development program progresses, we look forward to working closely with the FDA to potentially expedite the development and NDA review process. The next step will be the initiation of the FDA cleared Phase I/II clinical trial in the first half of 2009.”