FDA Accepts Allergan's sNDA for TEFLARO Use in Children

February 15, 2016

The U.S. Food and Drug Administration (FDA) has accepted Allergan’s supplemental New Drug Application (sNDA) for IV antibacterial TEFLARO® (ceftaroline fosamil).

If approved, this filing will expand the label of TEFLARO beyond adults to include children two months of age and older with 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. 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.

"The impact of ABSSSI and CABP are significant among children, particularly those under the age of five who are often hospitalized due to these infections. This acceptance brings us one step closer to providing another choice for physicians to properly treat pediatric patients with ABSSSI and CABP, including those infections caused by difficult-to-treat pathogens," says David Nicholson, Executive Vice President & President, Global Brands Research and Development, Allergan, in a news release. "We remain committed to the research and development of TEFLARO and our entire anti-infective portfolio to improve care and treatment of patients who have limited FDA approved options for these types of infections."

This application was based on results from five clinical studies evaluating TEFLARO in pediatric patients, including one active-controlled study in subjects with ABSSSI, two active-controlled studies in pediatric patients with CABP and two pharmacokinetic (PK) studies.

In the ABSSSI active-controlled study the efficacy and safety of TEFLARO were compared with vancomycin or cefazolin with or without aztreonam. In the CABP studies, TEFLARO was compared with ceftriaxone or ceftriaxone plus vancomycin. 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 submitted for this pediatric filing, 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.



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