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New Licence for Cubicin(R) (daptomycin), the First in a Novel Class of Antibiotic, is Announced Today for the Treatment of Serious Bloodstream and Heart Infections Caused by the Most Problematic UK Organisms, Including MRSA
Date:9/12/2007

already approved for the treatment of complicated skin and soft tissue infections (cSSTI) caused by Staphylococcus aureus and other Gram positive bacteria, including MRSA.(1) Clinical trials in cSSTI showed daptomycin had a faster time to cure (63% of patients successfully treated with daptomycin achieved a clinical cure within four to seven days versus 33% with comparators such as vancomyin and anti-staphylococcal penicillins).(6)

Pivotal trial data published in The New England Journal of Medicine supports the use of daptomycin in the treatment of bacteraemia and endocarditis caused by MRSA. The head-to-head study demonstrated daptomycin single agent therapy was as effective as dual agent comparator treatments and also has a favourable safety and tolerability profile with more creatine phosphokinase (CK) elevations but significantly fewer renal side effects reported versus comparator treatments.(2) The favourable safety profile is an important factor in severely ill patients.

A recent survey suggests that there is delay in patients receiving appropriate treatment for MRSA in approximately 50% of cases.(7) Delaying effective treatment for 48 hours can increase mortality as well as result in longer hospital stays, thus increasing the burden on the healthcare system.(8-11) Since Daptomycin is equally effective in treating MSSA and MRSA, it represents an important new empirical treatment choice for patients with MRSA bacteraemia associated with right sided endocarditis or complicated soft skin tissue infections.(2)

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Daptomycin was first approved in the UK in March 2006 and received a positive Scottish Medicines Consortium (SMC) recommendation for its use in treating complicated skin and soft tissue infections (cSSTIs) in March 2006.

Last month, The Committee for Medical Products for Human Use (CHMP) gave extended approval to daptomycin for the use in right-sided infective endocarditis (RIE) due to Staphylococcus aureus an
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SOURCE Novartis Pharmaceuticals UK Ltd
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