US FDA grants priority review status to Allergan’s sNDA for Avycaz


The US Food and Drug Administration (FDA) has granted priority review status for Allergan’s supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam) to treat hospital-acquired bacterial pneumonia / ventilator-associated bacterial pneumonia (HABP / VABP) in adult patients. 

The sNDA to include HABP / VABP as a new indication for Avycaz is based on the results obtained from a pivotal, multicentre, randomised double-blind Phase III Reprove study.

The US agency has granted priority review status for the application based on the previous qualified infectious disease product (QIDP) designation for Avycaz. 

Action on the filing is expected to be taken in the first quarter of next year. 

With the current sNDA filing status, the therapy will have the potential to be used for the third indication.

"If the avycaz sNDA is approved, healthcare providers will have a much-needed new treatment option for the management of HABP and VABP infections."

Allergan chief research and development officer Dr David Nicholson said: "The increasing prevalence of difficult-to-treat Gram-negative pathogens causing serious bacterial infections, like HABP and VABP, has resulted in a critical need for new effective treatments to combat these threats.

“Allergan is committed to bringing forward new therapies to address today's healthcare needs and to providing data that demonstrate the safety and efficacy of these therapeutics.

“We're encouraged by the filing acceptance; if the avycaz sNDA is approved, healthcare providers will have a much-needed new treatment option for the management of HABP and VABP infections.”

Avycaz, in combination with metronidazole, has already been approved in the US for the treatment of adult patients with complicated intra-abdominal infections (cIAI).

It can also be used to treat complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible bacteria including certain Enterobacteriaceae and Pseudomonas aeruginosa.