FDA to Review Pediatric Indication of Skin Infection Drug

The FDA is reviewing Allergan’s supplemental new drug application for ceftaroline fosamil (Teflaro) to treat children aged 2 months and older with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Teflaro was first approved in 2010 for the treatment of adults with ABSSSI and CABP.

If the FDA approves Allergan’s application, children with infections caused by methicillin-resistant Staphylococcus aureus and CABP caused by Staphylococcus pneumoniae and other designated susceptible bacteria could be treated with Teflaro.

“The impact of ABSSSI and CABP are significant among children, particularly those under the age of 5 who are often hospitalized due to these infections,” said David Nicholson, executive vice president and president, Global Brands Research and Development, Allergan, in a press release. “This acceptance brings us 1 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.”

Allergan’s application included data from 5 clinical studies that evaluated Teflaro in pediatric patients.

In an ABSSSI trial, 80.4% of patients treated with Teflaro saw a clinical response, meaning a cessation of lesion spread and no fever, by the third study day. Meanwhile, at day 3, 75% of the patients treated with vancomycin or cefazolin with or without aztreonam saw a clinical response.

The most common adverse effects associated with Teflaro include diarrhea, nausea, and rash.