Allergan asserts FDA’s approval for ssNDA for AVYCAZ

Allergan plc asserted that the U.S Food and Drug Administration has approved Allergan’s  supplemental New Drug Application to augment the use of AVYCAZ (ceftazidime and avibactam) to include the treatment of  hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms namely Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older.

The expanded use is based on positive results from a pivotal Phase 3 study evaluating the efficacy and safety of AVYCAZ for the treatment of adult patients with HABP/VABP. Certain types of Gram-negative bacteria have become increasingly resistant to available antibiotics, resulting in increased illness and death as well as contributing to escalating healthcare costs. New strategies have been long-awaited by the medical community.

David Nicholson, Ph.D., Chief Research and Development Officer, Allergan said “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.”

Jose Vazquez, M.D., FIDSA, Division Chief and Professor of Medicine Infectious Diseases, Medical College of Georgia/Augusta University said “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.”