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Vibativ approved to treat nosocomial pneumonia


Vibativ is a medicine that contains the active substance telavancin. It is available as a powder to be made up into a solution for infusion (drip into a vein).

 

Vibativ is used to treat adults with nosocomial pneumonia (an infection of the lungs). ‘Nosocomial’ means the infection was caught in hospital. This includes pneumonia caused by the use of a ventilator (a machine used in hospitals that helps patients to breathe). Vibativ is used only when the infection is known or believed to be caused by bacteria called ‘methicillin-resistant Staphylococcus aureus’ (MRSA) and when other treatments  (such as other antibiotics) are not suitable.
The medicine can only be obtained with a prescription.
Vibativ is given as a drip into a vein lasting one hour. The recommended dose is 10 mg per kg body weight once every 24 hours, for seven to 21 days. Kidney function should be monitored and the initial and subsequent doses may have to be lowered for patients with minor kidney problems, while treatment may need to be stopped if kidney function gets markedly worse.  
The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides’. It works by stopping the bacteria causing the infection from making their own cell walls and by disrupting their cell membranes, thereby killing the S aureus bacteria causing the infection.
MRSA is a S aureus bacteria that is resistant to commonly used antibiotics known as penicillins (including methicillin and oxacillin) and cephalosporins. Telavancin is used to treat MRSA because it can still work against bacteria that are resistant to these medicines.
The effects of Vibativ were first tested in experimental models before being studied in humans.
Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 1,503 adults with nosocomial pneumonia caused by Gram-positive bacteria (types of bacteria that include MRSA). The antibiotics were given for up to 21 days. Vibativ was also compared with vancomycin in two main studies involving a total of 1,897 adults with complicated infections of the skin and soft tissue below the skin caused by Gram-positive bacteria, where the medicines were given for up to 14 days. In all the studies, the main measure of effectiveness was the number of patients whose infection had been cured after the end of treatment.
Vibativ was as effective as the comparator medicine at curing nosocomial pneumonia and complicated infections of the skin and soft tissue. In the first study in nosocomial pneumonia, 58% of patients treated with Vibativ (214 out of 372) were cured after treatment compared with 59% of patients treated with vancomycin (221 out of 374). In the second study, 60% of patients treated with Vibativ (227 out of 377) were cured after treatment compared with 60% of patients treated with vancomycin (228 out of 380).
In the first study in complicated infections of the skin and soft tissue, 76% of patients treated with Vibativ (323 out of 426) were cured after treatment compared with 75% treated with vancomycin (321 out of 429). In the second study, 77% of patients treated with Vibativ (387 out of 502) were cured after treatment compared with 74% of those treated with vancomycin (376 out of 510).
The most common side effects with Vibativ (seen in more than 1 patient in 10) are dysgeusia (taste disturbances) and nausea (feeling sick). Studies showed that more patients developed kidney problems following treatment with Vibativ than with vancomycin (3.8% versus 2.2%). Vibativ should not be used in people who may be hypersensitive (allergic) to telavancin or any of the other ingredients. It must not be given to patients with severe kidney problems or acute (sudden) kidney failure. It must not be given to pregnant women.
The CHMP concluded that, although Vibativ had been shown to be effective in treating both nosocomial pneumonia and complicated infections of the skin and soft tissue, its toxic effect on the kidneys was an important safety concern. However, the Committee considered that Vibativ could be valuable for treating patients with nosocomial pneumonia known or believed to be caused by MRSA for whom other treatments are not suitable. Therefore, the CHMP decided that Vibativ’s benefits are only greater than its risks for patients who are severely ill with nosocomial pneumonia and are under close observation in hospital, and recommended that it be given marketing authorisation.
The company that markets Vibativ will ensure all doctors who are expected to prescribe or use Vibativ receive an educational pack containing a letter and a guide setting out important safety information on the correct use of Vibativ.
The European Commission granted a marketing authorisation valid throughout the European Union for Vibativ on 2 September 2011.
 

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Prepared by: Laila Nour


Source :

European Medicine Agency






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