FDA Grants QIDP Designation to Two Phase 3 Antibiotics
Cubist Pharmaceuticals announced that the FDA has designated two of the company's antibiotic candidates, CXA-201 (ceftolozane/tazobactam) and CB-315, as Qualified Infectious Disease Products (QIDP); CXA-201 has been designated for the treatment of complicated intra-abdominal infections, while CB-315 has been designated for Clostridium difficile-associated diarrhea (CDAD). Ceftolozane/tazobactam is a third generation cephalosporin/beta-lactamase inhibitor, while CB-315 is an antibacterial lipopeptide.
The QIDP designations will enable Cubist to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for fast-track status, and if CXA-201 or CB-315 are ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. These incentives are provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which was signed into law by President Obama in July 2012 as part of the FDA Safety and Innovation Act (FDASIA), the fifth authorization of the Prescription Drug User Fee Act.
CXA-201 is currently being studied in pivotal Phase 3 trials as a first-line intravenous therapy. It is also being evaluated for complicated urinary tract infections caused by Gram-negative bacterial infections (including those caused by multi-drug resistant Pseudomonas aeruginosa). CB-315 is currently being investigated in Phase 3 trials as an oral therapy.For more information visit www.cubist.com.