Allergan asks US regulators for priority review on Avycaz sNDA

EU approval for Celltrion’s trastuzumab biosimilar

US regulators have accepted Allergan’s supplemental New Drug Application of Avycaz for priority review.

The filing seeks to expand the current indications for Avycaz to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) in adult patients based on positive results from a Phase 3 clinical trial.

The US FDA granted priority review status to the application based on the previous Qualified Infectious Disease Product designation for Avycaz, and is expected to take action on the filing in the first quarter of 2018.

Pending the approval, this will be the third indication for Avycaz.

It was first approved in February 2015 in the US for the treatment of adult patients with complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections caused by designated susceptible bacteria.

This application seeks to add a new indication in the label based on favourable results from a pivotal Phase 3 study evaluating the efficacy and safety of Avycaz for the treatment of adult patients with HABP/VABP.