Novartis launched the novel antibiotic, Cubicin (daptomycin), for treating serious bloodstream and right-sided infective endocarditis infections caused by methicillin-sensitive and resistant Staphylococcus aureus (MSSA and MRSA) in the UK today. Already approved to treat complicated skin and soft tissue infections (cSSTI) caused by Staphylococcus aureus and other Gram positive bacteria, the new indications will address the growing incidence of bacteraemia which is associated with serious complications, including endocarditis in 30-40% of cases. MRSA is a frequent cause of bacteraemia, which affects over 7,000 people in the UK each year.
Cubicin, the first in the class of cyclic lipopeptides, is rapidly bactericidal, unlike most other antibiotics used to treat MRSA which prevent growth of bacteria rather than killing the infection. Its mode of action means there is no cross resistance to existing classes of antibiotics and that resistance may be slow to emerge.
"Serious staphylococcal infections are extremely challenging for hospital specialists to treat, with about 40% in the UK now resistant to first line therapy," commented Dr Andrew Seaton, consultant in infectious diseases at Gartnavel General Hospital in Glasgow. "Daptomycin is a fast acting agent in these potentially difficult situations and is well tolerated by patients. This is an extremely important and welcomed development in the battle against serious MRSA infection."
Cubicin has been shown to be as effective as vancomycin, the current first line treatment for MRSA, achieving a clinical success rate of 69% compared with 67% for vancomycin. The new antibiotic also has faster onset of action than alternative treatments, with potential to reduce morbidity and mortality resulting from delaying treatment of MRSA. In clinical trials 63% of patients were successfully treated with Cubicin in seven days compared with 33% treated with comparator antibiotics. It also has a favourable safety and tolerability profile with more creatinine phosphokinase elevations but significantly fewer renal side-effects compared with other treatments. The once-daily dosing and no requirement for serum drug monitoring has potential to simplify the management of patients with complicated infections.
Novartis received extended approval of Cubicin for the bacteraemia and heart indications in the EU last month. The UK is the first European launch for the new indications, with introduction in Germany planned next. Cubicin was approved in the UK for use in cSSTIs in March 2006 and received a positive recommendation from the Scottish Medicines Consortium (SMC) for this indication in the same month. Although more expensive than vancomycin at £62 for 350mg and £88.50 for 500mg, Cubicin was deemed to be cost-effective by the SMC, taking into consideration the costs involved in dose adjustment required with vancomycin.