Allergan Says FDA Accepts SNDA For TEFLARO

(RTTNews) - Allergan plc (AGN) announced the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application or sNDA for TEFLARO (ceftaroline fosamil).

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.

The 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 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.