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FDA Approves Expanded Label for IV Antibiotic Daptomycin
The FDA decision today follows the positive recommendations of the Anti-infective Drugs Advisory Committee, which at its March 6th meeting reviewed data from a landmark Phase 3 trial conducted by Cubist, a study of the efficacy and safety of CUBICIN at 6 mg /kg once-a-day as monotherapy vs. dual therapy standard of care therapy (semi synthetic penicillin plus initial gentamicin for infections caused by MSSA or vancomycin plus initial gentamicin for infections caused by MRSA) for the treatment of S. aureus bacteremia and endocarditis.
Mike Bonney, President and CEO of Cubist said, "I'm very proud of the team that conceived, conducted, and presented this historic study to the FDA. I am also thankful to the infectious disease experts and FDA scientists who worked with us, the investigators at 76 sites in the U.S. and Europe, and the patients who were treated as part of the clinical trial. The approval received today provides the clinicians who treat these complicated infections with an alternative therapy backed by prospectively collected, controlled, and comparative clinical data. Based on the expanded label approved today, we are very comfortable confirming our previously issued U.S. net product revenue guidance for 2006 of between $190 and $205 Million."
Dr. Ralph Corey said, "Doctors who treat patients with bloodstream infections caused by S. aureus, particularly for infections caused by MRSA, need alternative therapies. The "Bad Bugs/No Drugs" initiative of the Infectious Disease Society of America has identified MRSA as one of six top priority, dangerous, drug resistant microbes. The FDA approval of CUBICIN today for the treatment of these complicated, and life threatening infections is good news." Dr. Corey is professor of Medicine and Infectious Disease at Duke University Medical Center and director of Infectious Disease at Duke Clinical Research Institute. Dr. Corey chaired the Independent External Adjudication Committee (IEAC) which, blinded to therapy, assessed outcomes for all patients in the Phase 3 trial.
CUBICIN was originally approved on September 12, 2003, at 4 mg/kg intravenously once daily for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive organisms, including both susceptible and resistant strains of S. aureus (MSSA and MRSA respectively). In September of 2005, Cubist submitted to the FDA a sNDA for an expanded label. The file was accepted and given Priority Review designation by the FDA on November 25th, followed by an FDA Approvable Letter on March 24th. The results of the Phase 3 trial on which the sNDA is based were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in December, 2005. The trial results showed that, for the treatment of S. aureus bacteremia and endocarditis, CUBICIN at 6 mg/kg intravenously once daily met both primary end points for non-inferiority vs. comparator consisting of dual therapy (semi synthetic penicillin plus initial gentamicin for infections caused by MSSA or vancomycin plus initial gentamicin for infections caused by MRSA.) For full prescribing information, visit www.cubicin.com.
About CUBICIN® (daptomycin for injection)
CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. for the following infections:
Complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: S. aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). S. aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant S. aureus.
CUBICIN is not indicated for the treatment of pneumonia. Patients with persisting or relapsing S. aureus infection or poor clinical response should have repeat blood cultures. If a culture is positive for S. aureus, MIC susceptibility testing of the isolate should be performed using a standardized procedure, as well as diagnostic evaluation to rule out sequestered foci of infection. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. For full prescribing information, visit www.cubicin.com.
Source: Cubist Pharmaceuticals