FDA accepts Actavis’ sNDA to expand Teflaro labeling for ABSSSI with concurrent bacteremia

Teflaro is designed to treat acute ABSSSI caused by susceptible bacterial isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumonia and Klebsiella oxytoca.

Concurrent bacteremia, which can be fatal in most serious cases, is a secondary infection that occurs when bacteria spreads from the primary site of infection to the blood stream.

Actavis senior vice-president Global Brands Research and Development David Nicholson said: "The incidence of S. aureus bacteremia and its complications has increased sharply in recent years due to the rise in frequency of invasive procedures, higher numbers of immunocompromised patients and greater resistance of S. aureus strains to available antibiotics.

"We are pleased with the FDA’s acceptance of this sNDA and believe a label expansion has the potential to make a meaningful difference for patients and physicians in desperate need of alternative treatment options."

The sNDA was based on a subset of data from two identical pivotal trials CANVAS 1 and 2, which compared ABSSSI patients treated with Teflaro monotherapy to patients treated with vancomycin plus aztreonam.

In order to complete the review, the FDA has set the anticipated Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2015.