FDA Approves Pediatric Infection Treatment
Teflaro treats acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia (CABP).
Pediatric patients may now use ceftaroline fosamil (Teflaro) as a treatment for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
The FDA has approved Allergan’s supplemental new drug application to include an indication for patients aged 2 months to younger than 18 years.
Teflaro marks the first branded IV antibiotic for pediatric patients in more than a decade, according to Allergan.
"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 R&D Officer at Allergan, in a press release.
In trials, the safety and efficacy of Teflaro was proven when compared with vancomycin or cefazolin for ABSSSI. In CAPB studies, the treatment was compared with ceftriaxone.
In a ABSSSI patient population, Telfaro was able to stop lesion spread and fever better than a comparator group. Clinical cure rates were 94.4% of the 107 patients treated with Teflaro, and 86.5% for the comparator.
In a CABP patient population, investigators wanted to see if Teflaro could improve at least 2 of 7 symptoms (cough, dyspnea, chest pain, sputum production, chills, feverish feelings, and exercise intolerance or lethargy). Clinical cure rates were similar (87.9% for Teflaro patients and 88.9% for the comparator).
Teflaro was first approved as a treatment of CABP and ABSSSI among adults in October 2010.
Some of the adverse effects associated with TEFLARO include diarrhea, nausea, and rash, specifically in adult patients. Pediatric patients experienced the same symptoms, as well as vomiting and pyrexia. Thus far, no drug-drug interaction studies have been conducted with Teflaro.