Benitec Biopharma Limited announced that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to BB-301 for the treatment of oculopharyngeal muscular dystrophy (OPMD). Please find today’s full press release attached for your reference.
The Orphan Drug Designation granted to Benitec may provide a range of valuable benefits, including fast track process for clinical regulatory approval, potential extension of patent life with a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees. In short, a clear and expeditious path for cost-efficient development and commercialisation. The granting of orphan status from the FDA in the US follows on from receiving orphan designation from the European Medicines Agency in early 2017.