The FDA has approved ceftaroline fosamil (Teflaro), an injectable cephalosporin antibiotic, to treat adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).
“These are serious and potentially life-threatening infections for which new treatment options are needed,” said Edward Cox, MD, of the FDA’s Center for Drug Evaluation and Research.
Ceftaroline (Teflaro) was evaluated in 4 separate clinical trials, in patients ages 18 years and older (two each in CABP and in ABSSSI).
In the CABP trials, the effectiveness of ceftaroline was comparable to ceftriaxone, a proven antibiotic.
In the ABSSSI trials, Ceftaroline demonstrated efficacy and safety comparable to the control arm of vancomycin plus aztreonam.
The drug should not be used in patients with sensitivities to cephalosporin antibiotics. The most commonly reported side effects were diarrhea, nausea, and rash.
Source: MedPage Today