Actavis : FDA Approves New Antibacterial Drug Avycaz

(RTTNews) - Actavis plc (ACT) announced the U.S. Food and Drug Administration (FDA) has approved AVYCAZ (ceftazidime-avibactam). AVYCAZ was approved for the treatment of adult patients with complicated intra-abdominal infections or cIAI (in combination with metronidazole) and complicated urinary tract infections or cUTI including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.

AVYCAZ received a priority review based on Phase II data from the company's clinical development program and supporting in vitro data, and as such should be reserved for use in patients who have limited or no alternative treatment options.

AVYCAZ combines ceftazidime, a cephalosporin with in vitro activity against certain Gram-negative and Gram-positive bacteria, and avibactam, a non-beta-lactam beta-lactamase inhibitor that inactivates certain key beta-lactamases and protects ceftazidime from degradation by these beta-lactamases.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by Extended Spectrum Beta-Lactamases (ESBL), Klebsiella pneumoniae carbapenemase (KPC) and AmpC producing pathogens. AVYCAZ is part of Actavis' leading portfolio of infectious disease products that address some of the most dangerous pathogens.

AVYCAZ was granted priority review and approval as a Qualified Infectious Disease Product (QDIP) in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which made it eligible for the FDA's fast-track program and a five-year regulatory extension of exclusivity under the Hatch-Waxman Act.

AVYCAZ will be available in the second quarter of 2015.