FDA expands indication of Teflaro for pediatric patients with CABP, ABSSSIs

The FDA has expanded the indication for Teflaro, an injectable antibiotic in the cephalosporin class, to treat pediatric patients aged 2 months to 18 years with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, including MRSA.

Known to be common causes of health care visits and hospitalizations among children, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) have shown increasing prevalence. Recent studies have determined that 70,000 hospitalizations for ABSSSIs occur among children each year, with a twofold increase in incision and drainage procedures over a 13-year period.

“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,” C. David Nicholson, PhD, head of brand research and development at Allergan, said in a press release.

The FDA based its decision in part on results from clinical studies evaluating Teflaro (ceftaroline fosamil, Allergan) among pediatric patients aged 2 months to less than 18 years: two active-controlled studies in CABP, in which ceftaroline fosamil was compared with ceftriaxone, and one active-controlled study in ABSSSI, in which the efficacy/safety of ceftaroline fosamil was compared against vancomycin or cefazolin with optional aztreonam.

Results from the clinical studies in pediatric patients showed that ceftaroline fosamil demonstrated a safety profile that was well-matched with treatment of ABSSSI and CABP at the clinical dosages examined. The research findings for ceftaroline fosamil were similar to those seen in the adult studies, and no safety concerns were noted beyond those already recognized to be cephalosporin class effects.

“These new indications are yet another testament to our ongoing research and development in anti-infectives to address the evolving challenges of serious infections,” Nicholson said in the release. “Importantly, it allows us to educate physicians on the data they need to prescribe [ceftaroline fosamil] 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.”

The most common adverse reactions, which occurred in at least 3% of patients receiving ceftaroline fosamil in the pooled pediatric clinical trials, included diarrhea (8%), rash (7%), vomiting (5%), pyrexia (3%) and nausea (3%).