The US Food and Drug Administration (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).
Concurrent bacteremia is a secondary infection that occurs when bacteria spreads from the primary site of infection to the blood stream. Concurrent bacteremia complicates infection treatment and in the most serious cases can be fatal.
"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," said David Nicholson, senior vice president, global brands research and development, Actavis. "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 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 per cent) and higher response at Study Day 3 (65 per cent), 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.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target of Q3 2015 to complete its review.
Teflaro is a broad-spectrum bactericidal cephalosporin with activity against both gram-positive pathogens and gram-negative pathogens. Teflaro is indicated for the treatment of CABP, including cases caused by Streptococcus pneumoniae bacteremia, and ABSSSI, including cases caused by MRSA. In clinical trials, Teflaro was generally well-tolerated with an adverse event profile consistent with the cephalosporin class of antibiotics.
Forest obtained the worldwide rights (excluding Japan, where Takeda Pharmaceuticals holds rights) to Teflaro in 2007 when it acquired Cerexa, Inc., a privately held biopharmaceutical company. In August 2009, Forest Laboratories and AstraZeneca entered into a definitive collaboration agreement to co-develop and commercialise ceftaroline fosamil in all markets outside the US, Canada and Japan.
Teflaro is indicated for the treatment of acute ABSSSI caused by susceptible bacterial isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.
Teflaro is also indicated for the treatment of CABP caused by susceptible bacterial isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.