ABOUT DATAMONITOR HEALTHCARE
- About the CNS pharmaceutical analysis team
EXECUTIVE SUMMARY
- Introduction
- Scope and coverage of the Brief
- Key findings
TYSABRI - THE STORY SO FAR
- Tysabri withdrawn from market
- Overview of Tysabri
- Suspension of Tysabri - February 2005
- Linking Tysabri and PML
- Tysabris mechanism of action
- PML
- PML pathology
- Linking Tysabri and PML
- Tysabri monotherapy versus Tysabri/Avonex combination therapy
- Profile of PML patients
- Tysabri plus Avonex leads to drug accumulation and immune supression
CLINICAL TRIAL DATA
- AFFIRM two-year data
- SENTINEL one-year data
- SENTINEL two-year data
- GLANCE data
- ENCORE data - Crohns disease
DATAMONITOR ASSESSMENT AND THOUGHT LEADER OPINION
- Leading neurologists split on Tysabri monotherapy safety
- Action to be taken for Tysabris relaunch
- Potential product labeling of Tysabri
- Tysabri in immunosuppressed patients
- Screening of treatment-na・e and actively treated patients to reduce the risk of PML development
- Formulation of a treatment strategy to be executed if Tysabri patients develop PML
- How will Tysabri be positioned as a treatment strategy?
- Future clinical trials in MS
- Datamonitor Tysabri and monoclional antibody outlook
INTERVIEW TRANSCRIPTS
- Leading neurologists split on Tysabri monotherapy safety
- Interview 1
- Interview 2
- Interview 3
- Interview 4
- Interview 5
- Interview 6
- Interview 7
- Interview 8
- Interview 9
- Interview 10
APPENDIX
- Interviewed KOLs
- Bibliography
- Websites
- Journals and conference abstracts
- Research methodology
- Disclaimer
- List of Tables
- Table 1: Pharmacokinetics of Tysabri and Tysabri/Avonex at 20 weeks of treatment
- Table 2: Details of Tysabri patients with PML
- Table 3: Events since the withdrawal of Tysabri from market in February 2004
- List of Figures
- Figure 1: SWOT analysis of Tysabri
- Figure 2: Tysabri precautions
- Figure 3: Humira black box warning and strong warning on risk of infection
- Figure 4: Remicade black box warning and strong warning on risk of infection
- Figure 5: Novartiss Clozaril CARE website - WBC and ANC monitoring
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