The first in a new class of antibiotics has been approved in the USA for the treatment of complicated skin and soft structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
Cubist Pharmaceuticals' Cubicin (daptomycin for injection), formerly developed under the Cidecin banner, is the first cyclic lipopeptide to be cleared for marketing. The company plans to make the drug commercially available in early November.
The approved indication covers a range of serious infections, usually occurring in hospitalised patients, and include major abscesses, post-surgical skin wound infections and infected ulcers.
The US Food and Drug Administration (FDA) said that Cubicin "treats infections in a way that is distinct from any other antibiotic." It works by inhibiting lipoteichoic acid synthesis; lipoteichoic acid is a key component of the peptidoglycan cell wall in Gram-positive bacteria. Daptomycin's mechanism of action differs from that of another antibacterial class, the glycopeptides, which also target peptidoglycan synthesis.
In 2002, doctors prescribed an estimated seven million courses of IV antibiotics for patients with complicated skin and skin structure infections in US hospitals, according to the FDA. Meantime, Cubist suggests that around 600,000 patients contract complicated skin and soft tissue structure caused by MRSA each year in the USA.
"The approval of Cubicin is particularly important as we face the growing public health crisis of bacterial resistance," said Robert Weinstein, chairman of the division of infectious diseases at Stroger Hospital of Cook County in Chicago and a Cubist scientific advisor.
"There has been a frightening increase in MRSA infections over the past decade, and the tools currently available to combat this problem have become less effective," he added.