CUBICIN ® (daptomycin for injection) for S. aureus Bacteremia Including Those With Known or Suspected Endocarditis - PowerPoint PPT Presentation

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CUBICIN ® (daptomycin for injection) for S. aureus Bacteremia Including Those With Known or Suspected Endocarditis PowerPoint Presentation
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CUBICIN ® (daptomycin for injection) for S. aureus Bacteremia Including Those With Known or Suspected Endocarditis

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  1. CUBICIN® (daptomycin for injection) for S. aureus Bacteremia Including Those With Known or Suspected Endocarditis David Mantus, Ph.D. Vice President, Regulatory AffairsCubist Pharmaceuticals Adjunct Assistant ProfessorMassachusetts College of Pharmacy

  2. Adjudication Committee Member and Affiliation

  3. Experts Available for Questions and Answers

  4. What is Daptomycin? • Cyclic lipopeptide natural product • Approved (IV, 4 mg/kg q24h) for complicated skin and skin structure infections, including MRSA • US 2003 • Israel 2004 • Argentina 2005 • EU 2006

  5. Post-licensure Experience • 150,000+ patients treated • No new toxicities • ~1/3 of doses delivered in outpatient setting • Potency vs. S. aureus maintained • Microbiologic surveillance studies demonstrate> 99.9% of isolates are daptomycin susceptible • ~25% of use is for bacteremia (off-label) • ~50% of this use at the 4 mg/kg dose approved for skin, NOT the 6 mg/kg dose studied in S. aureus bacteremia

  6. Rationale for Daptomycin in S. aureus Bacteremia and Endocarditis • Rapidly bactericidal in vitro and in vivo • Potency against MRSA and MSSA • Proven clinical efficacy in skin (MRSA and MSSA) • Proven efficacy in animal models of S. aureus endocarditis at 6 mg/kg human equivalent dose • Potential for outpatient treatment • Monotherapy • Once-daily

  7. Continuous Dialogue with FDA on Development • Study design (2001-2002) • Open-label • Comparators • Enrollment of all patients with S. aureus • Data Safety Monitoring Board • Study assessments and analyses (2004-2005) • Adjudication Committee • Primary endpoints • Statistical Analysis Plan agreed upon prior to unblinding • Study results (2005) • sNDA filed • Priority review granted

  8. S. aureus Bacteremia and EndocarditisSupplemental Indication and Dose • Proposed Indication • Staphylococcus aureus bacteremia (SAB) including those with known or suspected endocarditis (SAIE) caused by methicillin-susceptible and methicillin-resistant strains • Proposed Dose • 6 mg/kg monotherapy administered as a 30-minute intravenous (IV) infusion once per day for a minimum duration of 2 to 6 weeks, depending on theclinical condition

  9. Agenda Introduction David Mantus, Ph.D.V.P. Regulatory AffairsCubist Pharmaceuticals Efficacy Helen Boucher, M.D.Assistant Professor of MedicineDir. Infectious Diseases Fellowship ProgramDiv. of Infectious Diseases and Geographic MedicineTufts University-NEMC Microbiology Jeff Alder, Ph.D.V.P. Drug Discovery & EvaluationCubistPharmaceuticals Safety Gloria Vigliani, M.D.V.P. Medical StrategyCubist Pharmaceuticals Conclusions G. Ralph Corey, M.D.Professor of Internal Medicine & Infectious DiseaseDuke University Medical Center

  10. Overall Findings Daptomycin 6 mg/kg once daily: • Effective in the treatment of S. aureus bacteremia and endocarditis • Response higher in MRSA • Well tolerated for extended treatment durations • Less nephrotoxic than standard-of-care agents • Provides a much needed option for treatment of patients with S. aureus bacteremia including those with known or suspected endocarditis