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FDA Accepts Supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil)

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Additional Relevant Details 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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Occurred on:
Feb 16, 2016
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Related Keywords Teflaro, Ceftaroline Fosamil, Skin Structure Infections, Acute Bacterial Skin Infection, Staphylococcus Pneumoniae