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.
Please Log In to add a comment.
Best of TechWire Insider
- Star Trek gets real: Durham startup delivers interactive holograms
- Every tech company needs to join 'Global Government Surveillance Reform' movement
- Durham entrepreneurs find ally in Charlotte medtech incubator
- GoGown deal shows power, necessity of networking for startups
- New GSK oncology consortium targets combination therapies
- Fighting hospital infections: A Durham nurse's dream produces the GoGown
- From photos to out-of-this-world art: Raleigh firm's software transforms images
- LabCorp expands gene tests for cancer - but don't confuse these with 23andMe
- ChannelAdvisor: Mobile cuts deeply into PC share of online shopping
- Inside Appia's latest funding deal: Debt beats dilution