CUBICIN
Download
1 / 10

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

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha

Download Presentation

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

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Slide1 l.jpg
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




What is daptomycin l.jpg
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


Post licensure experience l.jpg
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


Rationale for daptomycin in s aureus bacteremia and endocarditis l.jpg
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


Continuous dialogue with fda on development l.jpg
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


S aureus bacteremia and endocarditis supplemental indication and dose l.jpg
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


Agenda l.jpg
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


Overall findings l.jpg
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


  • Login