BioCentury
ARTICLE | Clinical News

Avarofloxacin regulatory update

March 4, 2013 8:00 AM UTC

Furiex said FDA granted Qualified Infectious Disease Product (QIDP) designation for avarofloxacin to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The product has completed Phase II trials in ABSSSI, CABP and methicillin-resistant Staphylococcus aureus (MRSA) infection. Furiex is seeking a partner to pursue Phase III development of avarofloxacin. The compound is now eligible for an additional 5 years of market exclusivity and will automatically receive Priority Review and Fast Track designation under the Generating Antibiotic Incentives Now (GAIN) program. GAIN, which creates incentives to develop new drugs against pathogens with "the potential to pose a serious threat to public health," is part of the FDA Safety and Innovation Act signed into law last year. ...