Cubicin (daptomycin) has received European Commission approval for expanded use in helping patients suffering from two types of life-threatening bacterial infections that commonly occur during hospital stays, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA) strains.
The two new indications approved for Cubicin 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. If not quickly and effectively treated, up to one-third of these patients may die from the infections. With growing resistance to current treatments, these types of infections are becoming an increasingly serious public health challenge.
The use of Cubicin in treating patients with bacteremia and endocarditis caused by S aureus has been supported by landmark 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[1]. 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 and founding member of the German League for Infectious Diseases. "Daptomycin was proven to treat both infections with equal efficacy and overall favourable safety and tolerability."
As the first in a new class of antibiotics called cyclic lipopeptides, Cubicin rapidly resolves serious Gram-positive hospital infections with a unique mode of action, killing bacteria rather than limiting growth, resulting in negligible bacterial cell lysis. This means that dead bacteria are left intact, preventing them from releasing their toxic contents into the bloodstream.
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.
"Expanding the use of Cubicin for additional life-threatening infections signals our commitment to the challenges of increasing resistance to many antibacterials in the hospital setting," said James Shannon MD, Global Head of Development at Novartis Pharma AG.
"Cubicin offers physicians an effective and well-tolerated therapeutic option that can be used quickly and easily to help patients begin recovery rapidly".
Cubicin was developed by, and is a registered trademark of, Cubist Pharmaceuticals, Inc., which markets the product in the US for the treatment of complicated skin and skin structure infections and S aureus bacteremia, including right-sided endocarditis. Novartis has the exclusive rights to commercialize Cubicin across Europe, Australia, New Zealand, India, and certain countries in Central America, South America and the Middle East.