Cubist's Late-Stage Antibiotics Granted QIDP Designation and Fast Track Status
Cubist Pharmaceuticals announced that the FDA has designated its late-stage antibiotic candidate, ceftolozane/tazobactam, as a Qualified Infectious Disease Product (QIDP) for the indications of hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) and complicated urinary tract infections (cUTI). In addition, the FDA has granted Fast Track Status for its antibiotic candidates, ceftolozane/tazobactam and surotomycin in their previously granted QIDP indications, complicated intra-abdominal infections (cIAI) and Clostridium difficile-associated diarrhea (CDAD) respectively.
Ceftolozane/tazobactam is currently being studied in pivotal Phase 3 trials as a potential first-line IV therapy for the treatment of cIAI and cUTI caused by gram-negative pathogens, including those caused by multi-drug resistant Pseudomonas aeruginosa. Cubist expects to initiate a Phase 3 VABP program for ceftolozane/tazobactam by mid-year. Surotomycin, a rapidly bactericidal lipopeptide, is currently in Phase 3 being studied as a potential treatment for patients with a severe and sometimes life-threatening diarrhea caused by CDAD.For more information call (866) 793-2786 or visit www.cubist.com