Actavis files sNDA with FDA for Teflaro in ABSSSI-Actavis

The FDA has accepted for filing Actavis' supplemental New Drug Application (sNDA) to expand the label for Teflaro (ceftaroline fosamil) to treat cases of concurrent bacteremia in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) caused by susceptible isolates of Staphylococcus aureus (including Methicillin-susceptible and resistant isolates).

The submission was based on a subset of data coming from two identical pivotal trials (CANVAS 1 and 2) comparing ABSSSI patients treated with TEFLARO monotherapy to patients treated with vancomycin plus aztreonam. Clinical response was evaluated at Test of Cure (TOC) and Study Day 3 in subjects who had S. aureus bacteremia at baseline in the microbiological modified intent-to-treat (mMITT) population. TEFLARO patients showed a comparable response at TOC (90%) and higher response at Study Day 3 (65%), compared to patients treated with vancomycin/aztreonam. Supportive evidence is provided by data from an investigator-conducted case control study, literature reports, microbiological surveillance, and animal model studies.