FDA Incentives Spur Development of New Antibiotic
Delafloxacin designed for first-line use in hospitals (Sept. 17)
Rib-X Pharmaceuticals, Inc., based in New Haven, Conn., announced on September 17 that the FDA has designated delafloxacin as a qualified infectious disease product (QIDP) for the indications of acute bacterial skin and skin-structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
The QIDP designation will enable Rib-X to benefit from certain incentives for the development of new antibiotics, including an additional 5 years of market exclusivity, priority review, and eligibility for fast-track status, provided under the new Generating Antibiotic Incentives Now (GAIN) program.
GAIN was included in the FDA Safety and Innovation Act (FDASIA), formerly known as PDUFA V, which was signed into law by President Obama in July 2012.
Delafloxacin is being developed for use as a first-line antibiotic primarily in hospitals prior to the availability of a specific diagnosis. The drug has the potential to offer broad-spectrum coverage as monotherapy, including for methicillin-resistant Staphylococcus aureus (MRSA), with both intravenous (IV) and oral formulations. With the exception of Zyvox (linezolid), all other currently approved treatments for MRSA are administered only via the IV route.
In addition to gram-positive potency, delafloxacin has shown in vitro activity against susceptible gram-negative bacteria. Rib-X recently reported data from a successful phase IIb study in which delafloxacin met or exceeded primary and secondary efficacy endpoints in comparison with Zyvox, with and without aztreonam, and in comparison with vancomycin, with and without aztreonam.
Delafloxacin has shown promising results for the treatment of lung infections, including pneumonia and bronchitis, and skin infections in four phase II trials. Rib-X is developing both IV and oral formulations of delafloxacin to enable patients who begin IV treatment in the hospital setting to transition to oral dosing for home-based care.
For more information, visit the Rib-X Pharmaceuticals Web site.