Cubist Pharmaceuticals has received the US Food and Drug Administration (FDA) fast track status for its late-stage antibiotic candidate ceftolozane/tazobactam in the previously granted Qualified Infectious Disease Product (QIDP) indications, Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and Complicated Urinary Tract Infections (cUTI).
In February 2013, the Agency had granted Fast Track status for ceftolozane/tazobactam in Complicated Intra-Abdominal Infections (cIAI).
Cubist Pharmaceuticals Chief Scientific Officer Steven Gilman said that the incentive, enabled by the GAIN Act, will help the company expedite the development of ceftolozane/tazobactam across many types of serious and potentially life-threatening infections.
The QIDP designation for ceftolozane/tazobactam allows Cubist to benefit from certain incentives for the development of new antibiotics, including Priority Review, the Fast Track status designation provided.
These incentives are provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which received strong bipartisan support and 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.
Ceftolozane/tazobactam is currently being studied in pivotal Phase 3 trials as a potential intravenous therapy for the treatment of cIAI and cUTI caused by Gram-negative pathogens.
