Allergan: FDA To Review SNDA For AVYCAZ; Filing Seeks To Expand Label

(RTTNews) - Allergan plc (AGN) announced the U.S. FDA has accepted a supplemental New Drug Application (sNDA) for AVYCAZ for priority review. The sNDA filing seeks to expand the current indications for AVYCAZ to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia in adult patients based on positive results from a Phase 3 clinical trial.

The company said the FDA has 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.