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Allergan's Avycaz becomes first FDA-approved gram-negative antibiotic in over 15 years

Published on 02/02/18 at 09:28am

Allergan has announced that the FDA has awarded approval to its fixed-dose combination antibacterial Avycaaz (ceftazidme and avibactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adult patients. The decision marks the first approval for a gram-negative antibiotic in the US in over 15 years.

The list of pneumonia-causing susceptible Gram-negative microorganisms which Avycaz is indicated to effectively treat includes Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenza.

The FDA’s decision came on the back of Phase 3 data derived from 870 patients who were randomised to receive either 2.5g of Avycaz or 1g of meropenem intravenously every eight hours for 7 to 14 days of therapy. It was found that Aycaz proved non-inferior to meropenem in 28-day all-cause mortality, with rates of 9.6% for Avycaz and 8.3% for meropenem.

"Healthcare providers in the US have not had access to a new treatment option for patients with HABP/VABP due to Gram-negative bacteria in over 15 years," said Dr David Nicholson, Chief Research and Development Officer at Allergan. "Gram-negative pathogens are some of the most pressing antibiotic resistance threats and cause more than 40,000 resistant infections in the US 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."

This is the third US approved indication for Avycaz after its approval for the treatment of complicated intra-abdominal infections in 2015, and for the treatment of complicated urinary tract infections in 2017.

"Clinical efficacy along with patient safety are critical priorities to clinicians managing serious Gram-negative bacterial infections. We are thrilled to have a new option available to treat HABP/VABP, some of the most challenging Gram-negative infections in the hospital setting," said Dr Jose Vazquez, FIDSA, Division Chief and Professor of Medicine Infectious Diseases, Medical College of Georgia/Augusta University.

Matt Fellows

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