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

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

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

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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


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Adjudication Committee Member and Affiliation


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Experts Available for Questions and Answers


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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

    • Argentina2005

    • EU2006


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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


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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


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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


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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


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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


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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


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