Cubist Pharmaceuticals’ antibiotic product Cubicin has been cleared by a US Food and Drug Administration advisory panel to treat a potentially life-threatening complication that can occur in patients infected with Staphylococcus aureus.
The Anti-Infective Drugs Advisory Committee voted unanimously that Cubicin (daptomycin for injection) was both safe and effective in the treatment of S aureus infections in the blood, and by a narrow margin (5 to 4) also backed its approval for infective endocarditis, an inflammatory reaction to bacteria colonizing the surface of the heart that can lead to heart failure and death.
The International Collaboration of Endocarditis, a clinical group focusing on understanding and treating the disease, believes that S aureus is now the leading cause of endocarditis and that the incidence of such infections is on the rise, with mortality remaining high and approaching 40% at one year.
Cubicin was approved in the USA in 2003 to treat complicated skin and soft tissue infections, and was the first in a new class of lipopeptide antibiotics to reach the market.
In January 2006 Cubist and its European partner Chiron also got the go-ahead from the European Medicines Agency (EMEA) in the skin and soft tissue indication, and started rolling out in the UK and the Netherlands. Sales of the antibiotic nearly doubled last year compared to 2004, reaching $114 million.
Cubist presented Phase III data at last December’s Intersciences Conference on Antimicrobial Agents and Chemotherapy showing that Cubicin was at least as effective as standard therapy (vancomycin or nafcillin) in treating blood and heart infections caused by both methicillin susceptible and methicillin resistant S aureus (MSSA and MRSA).
Cubicin is one of three antibiotics that have been tipped to grow strongly over the coming years as a result of the increasing prevalence of drug-resistant pathogens, according to a market report released in December by Decision Resources. The others are Pfizer's Zyvox (linezolid) and Sanofi-Aventis' Ketek (telithromycin).