FDA puts Furiex antibiotic on fast track for review
Morrisville, N.C. —
The Morrisville company announced that its experimental antibiotic avarofloxacin has been designated as a Qualified Infectious Disease Product (QIDP) and has been granted fast track status. Both designations give a compound priority review from the FDA and five years of market exclusivity if it the drug is approved. Furiex said that the designations would help Furiex, or a potential drug partner, develop the new antibiotic.
Avarofloxacin is ready to head into phase III clinical trials. In phase II studies, the compound was shown to be effective in treating acute bacterial skin and skin structure infections. Furiex says avarofloxacin has a low propensity for developing drug resistance and could be used on a broad range of infections, including methicillin-resistant Staphylococcus aureas, or MRSA.
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