FDA accepts sNDA for pediatric use of Teflaro (ceftaroline fosamil) in ABSSSI and CABP- Allergan

The FDA has accepted for filing the supplemental New Drug Application (sNDA) for Teflaro (ceftaroline fosamil), from Allergan. If approved, this filing will expand the label of Teflaro beyond adults to include the treatment of children two months of age and older with acute bacterial skin and skin structure infections (ABSSSI) including infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and community-acquired bacterial pneumonia (CABP) caused by Staphylococcus pneumoniae and other designated susceptible bacteria.

This application was based on results from five clinical studies evaluating Teflaro in pediatric patients, including one active-controlled study in subjects with ABSSSI (NCT01400867), two active-controlled studies in pediatric patients with CABP (NCT01530763 and NCT01669980) and two pharmacokinetic (PK) studies. In the ABSSSI pediatric trial, the clinical response at Study Day 3, as measured by cessation of lesion spread and absence of fever, was 80.4 percent (86/107) in patients treated with Teflaro and 75 percent (39/52) for the comparator group. The CABP pediatric trials evaluated the efficacy and safety of two separate dosing regimens of Teflaro. In the trial, the clinical response at Study Day 4, as measured by improvement in at least two out of seven symptoms (cough, dyspnea, chest pain, sputum production, chills, feeling of warmth/feverish and exercise intolerance or lethargy) as well as by no worsening of these symptoms, was 69.2 percent (74/107) for patients treated with Teflaro and 66.7 percent (24/36) in the comparator group.

Comment: Teflaro was first approved by the U.S. FDA in October 2010 for the treatment of adults with CABP and ABSSSI due to designated susceptible pathogens.