Table of Contents
Rapamune®
FDA Review Team
FDA Perspective: Rapamune®
Basis of Initial Approval (1999)
Phase 4 Commitment (1)
Phase 4 Commitment (2)
Proposed Labeling Change
Studies to Support Labeling Change
Sirolimus Dosing
Strengths and Weaknesses
Efficacy Considerations
Patient Population Study 310
Patient Population Study 212
Discontinuations During Treatment through Month 12
Reasons for Discontinuation Study 310
Patient and Graft Survival
Acute Rejection Following CsA Withdrawal
Renal Function at 12 Months
GFR (mL/min) at 12 Months*
Serum Creatinine (?mol/mL) at 12 Months*
GFR (mL/min) at 12 Months* By Rejection Status
Serum Creatinine (?mol/L) at 12 Months* By Rejection Status
Safety considerations
Mean Sirolimus Trough Concentration (ng/ml)
Analytical Issues
Treatment-emergent Adverse Events ᡌ % in the Rapamune NDA (1999)
Treatment-emergent Adverse Events > 5% and ង % in the Rapamune NDA (1999)
Liver Function Tests (LFT’s)
Infection and malignancy
Summary
Questions for the Advisory Committee #1
Questions for the Advisory Committee #1
Questions for the Advisory Committee #2
Questions for the Advisory Committee #3
PPT Slide
PPT Slide
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