Novartis Drug Gets EU Approval to Treat Hospital Infections
Posted on: Thursday, 6 September 2007, 15:07 CDT
Novartis's Cubicin drug has been approved by the European Commission for treating two life-threatening bacterial infections that commonly occur during hospital stays.
The two new indications approved for Cubicin (daptomycin) were right-sided infective endocarditis (RIE) due to staphylococcus aureus (S. aureus), an infection of the heart valve, and S. aureus bacteremia (SAB), a bloodstream infection, in cases when associated with RIE or with complicated skin and soft-tissue infections (cSSTI).
Cubicin first received European approval in January 2006 for use in treating cSSTI infections caused by gram-positive bacteria.
In the UK alone, more than 15,000 patients are estimated to contract SAB infections every year, according to the health protection agency. If not quickly and effectively treated, up to one-third of these patients may die from the infections.
The use of Cubicin in treating patients with bacteremia and endocarditis caused by S. aureus has been supported by trial data published in The New England Journal of Medicine.
A head-to-head study demonstrated that Cubicin was equally effective against both methicillin-susceptible and methicillin-resistant S. aureus bloodstream infections. Results also showed Cubicin successfully treated patients with SAB or RIE infections with the same efficacy as the current standards of care, which is vancomycin or semi-synthetic penicillin combined with initial gentamicin therapy.
Additionally, impaired kidney function, a common side-effect of antibiotics used to treat these infections, was significantly lower in patients receiving Cubicin than in those treated with the comparator drugs.
"With the growing rates of MRSA infections, the need to treat patients quickly - even before the infecting organism can be confirmed - is strong. Daptomycin can be used empirically to cure both methicillin-susceptible staphylococcus aureus and MRSA infections," said Dr Christoph Naber, assistant medical director of the department of cardiology at the University of Duisburg-Essen. "Daptomycin was proven to treat both infections with equal efficacy and overall favorable safety and tolerability."
Novartis says that while the current standard of treatment often requires combination therapies, Cubicin is a simpler approach to Gram-positive infections as a once-daily monotherapy that requires no routine therapeutic drug monitoring.
Source: Datamonitor
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