FDA Approves Supplemental NDA of Allergan’s Teflaro for Children with Pneumonia

FDA Approves Supplemental NDA of Allergan’s Teflaro for Children with Pneumonia

The U.S. Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA) for Teflaro (ceftaroline fosamil). The approval will result in new indications for pediatric patients ages 2 months to 18 years with acute bacterial skin and skin structure infections (ABSSSI), such as infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria. With the approval, Teflaro has become the first branded IV antibiotic approved for children in more than a decade.

The antibiotic, a bactericidal cephalosporin with activity against both Gram-positive and Gram-negative bacteria, demonstrated positive results in clinical trials evaluating its safety and tolerability as a pediatric ABSSSI and CABP therapy.

For the pediatric filing on pneumonia, Allergan conducted a study with 143 patients with CABP in the Modified Intent-to-Treat (MITT) population. Response rates were evaluated as measured by improvement on day 4 in at least two out of seven symptoms (cough, dyspnea, chest pain, sputum production, chills, feeling warm/feverish, and exercise intolerance or lethargy), and worsening in none of these symptoms.

At study day 4, the clinical response was 69.2 percent (74 of 107) for patients treated with Teflaro and 66.7 percent (24 of 36) for the comparator. Clinical cure rates at the test of cure (TOC) visit were 87.9 percent (94 of 107) for patients treated with Teflaro and 88.9 percent (32 of 36) for the comparator.

Teflaro demonstrated a safety profile compatible with treatment of ABSSSI and CABP at the clinical dosages studied. Moreover, the safety findings were similar to those observed in the adult studies and no new safety concerns were found.

“The impact of ABSSSI and CABP among children is significant, as these infections often require hospitalization and are met with limited pediatric treatment options, particularly as resistance increases among the pathogens that cause these infections,” said David Nicholson, chief research and development officer at Allergan.

“These new indications are yet another testament to our ongoing research and development in anti-infectives to address the evolving challenges of serious infections,” he said. “Importantly, it allows us to educate physicians on the data they need to prescribe Teflaro to appropriate pediatric patients in need of an option that is safe and effective against some of the most difficult-to-treat pathogens in ABSSSI and CABP.”

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