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FDA Approves Cubicin (Daptomycin), First In New Class Of Antibiotics

BETHESDA, MD -- September 15, 2003 -- The Food and Drug Administration (FDA) announced the approval of Cubicin (daptomycin for injection) for the treatment of complicated skin and skin structure infections. These are serious infections, usually occurring in hospitalized patients, and include major abscesses, post-surgical skin wound infections, and infected ulcers.

Cubicin is the first approved product in a new class of antibiotics called cyclic lipopeptide antibacterial agents. Cubicin treats infections in a way that is distinct from any other antibiotic.

The approval of Cubicin is part of FDA's ongoing efforts to help bring new types of antibiotics to patients to make sure there are treatment options available for serious infections. In 2002, doctors prescribed an estimated seven million courses of IV antibiotics for patients with complicated skin and skin structure infections in US hospitals.

Cubicin is specifically indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). Cubicin is not indicated for the treatment of pneumonia.

FDA based its decision to approve Cubicin on a review of clinical studies involving over 1400 adults that demonstrated the drug's safety and efficacy. The clinical studies demonstrated Cubicin was equivalent to standard treatments (i.e., vancomycin or a semi-synthetic penicillin such as oxacillin or nafcillin) in the treatment of complicated skin and skin structure infections.

Most adverse events reported in the clinical studies of Cubicin were mild to moderate in intensity. The most common adverse events included gastrointestinal disorders, injection site reactions, fever, headache, insomnia, dizziness, and rash.

Blood tests showing muscle injury were found rarely in patients in clinical trials. Most of these patients had no symptoms, and the blood tests returned to normal after therapy. Patients receiving Cubicin should be monitored for the development of muscle pain or weakness. Blood tests measuring creatine phosphokinase (CPK) levels should be monitored weekly in patients who receive Cubicin. Those who develop unexplained elevations in CPK while on Cubicin should be monitored more frequently.

Cubist Pharmaceutical Inc., of Lexington Mass., is the sponsor of the approved New Drug Application (NDA) for Cubicin.


SOURCE: FDA

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