Teflaro for the treatment of adults with community acquired bacterial pneumonia and acute bacterial skin and skin structure infections: FDA approved
The FDA ( Food and Drug Administration ) has approved Teflaro ( Ceftaroline fosamil ), an injectable 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 ).
Teflaro is an antibacterial agent in a class of drugs known as cephalosporins, which act by interfering with the bacterial cell wall.
Community acquired bacterial pneumonia is a bacterial infection that develops in the lungs of patients who are exposed to the bacteria in their normal environment, and not in the hospital.
ABSSSI is a bacterial infection of skin and skin structures that requires antibiotic treatment and may require surgical treatment.
MRSA is a type of staph bacteria that is resistant to certain antibiotics. These antibiotics include Methicillin and other more common antibiotics such as Oxacillin, Penicillin, and Amoxicillin.
In the community, most MRSA infections are skin infections. Severe or potentially life-threatening MRSA infections occur most frequently among patients in contact with health care settings.
The safety and effectiveness of Teflaro was evaluated in four, Phase 3 clinical trials in patients ages 18 years and older ( two each in CABP and in ABSSSI ).
In the CABP trials, the comparator antibacterial treatment was Rocephin ( Ceftriaxone ) and in the ABSSSI trials, the comparator antibacterial treatment was Vancocin ( Vancomycin ) plus Azactam ( Aztreonam ).
In the CABP trials, 1,231 adult patients received Ceftaroline or Ceftriaxone. Clinical response based on improvement in signs and symptoms of pneumonia on day 4 after starting therapy served as the key analysis endpoint. In both trials, the effectiveness of Ceftaroline was comparable to Ceftriaxone.
In the ABSSSI trials, 1,396 adult patients received Ceftaroline or Vancomycin plus Aztreonam. Clinical response, including cessation of spread of the lesion and absence of fever on Day 3, served as the key analysis endpoint. In both trials, Ceftaroline was comparable to Vancomycin plus Aztreonam.
The most commonly reported side effects in patients treated with Ceftaroline included diarrhea, nausea and rash. Teflaro should not be used in patients with sensitivities to cephalosporin antibiotics.
Source: FDA, 2010
XagenaMedicine2010
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