Allergan announced that the FDA approved its supplemental new drug application to expand the use of Avycaz to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, or HABP and VABP.
According to Allergan, the ruling expands the approved use of Avycaz (ceftazidime/avibactam) to treat HABP and VABP in patients aged 18 years or older that are caused by several susceptible gram-negative pathogens: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa and Haemophilus influenzae.
“Health care providers in the U.S. have not had access to a new treatment option for patients with HABP/VABP due to gram-negative bacteria in over 15 years,” David Nicholson, PhD, chief research and development officer for Allergan, said in a news release. “Gram-negative pathogens are some of the most pressing antibiotic resistance threats and cause more than 40,000 resistant infections in the U.S. annually. Today’s action by the FDA is further evidence of Allergan’s commitment to improving outcomes and meeting critical needs in patients with life-threatening infectious diseases.”
It is the third therapeutic indication for ceftazidime-avibactam, which was first approved in February 2015 to treat adults with complicated intra-abdominal infections, in combination with metronidazole. Last year, the FDA approved its use in patients with complicated urinary tract infections, including pyelonephritis, caused by gram-negative bacteria.
The most recent FDA approval was based on data from the phase 3 REPROVE trial showing that ceftazidime-avibactam was noninferior to meropenem for treating nosocomial pneumonia. The trial compared IV infusions of either 2 g of ceftazidime and 0.5 g of avibactam or 1 mg of meropenem every 8 hours for 7 to 14 days in 879 patients hospitalized with HABP or VABP. – by Gerard Gallagher
Disclosure: Nicholson works for Allergan.