Table of Contents
Clinical Review of Protopic Safety, Potential Risk, and Efficacy
Protopic Safety
Protopic Safety Data Base
Adverse Events--Adults: 3 weeks treatment
Adverse Events--Adults: 3 weeks treatment
Adverse Events--Adults: 12 weeks treatment
Adverse Events--Adults: 12 weeks treatment
Adverse Events--Adults: 6-12 months treatment
Adverse Events--Adults: 6-12 months treatment
Adverse Events--Pediatrics: 3 weeks treatment
Adverse Events--Pediatrics: 3 weeks treatment
Adverse Events--Pediatrics: 12 weeks treatment
Adverse Events--Pediatrics: 12 weeks treatment
Adverse Events--Pediatrics: 1 year treatment
Adverse Events--Pediatrics: 1 year treatment
Lymphadenopathy in Clinical Studies
Lymphadenopathy Etiology
Common Adverse Events: 3 Twelve Week Studies
Common Adverse Events: 2 One Year Studies with 0.1% ointment
Safety Conclusions
Safety Conclusions (cont’d)
Efficacy Database
Study Subjects
Study Protocol
Complete or ? 90% Clearing
Efficacy Outcomes
Power Analysis
-035 and -036 Population Subsets: 0.03% vs. 0.1%
-037 Population Subsets: 0.03% vs. 0.1%
037 Population Subsets: 0.03% vs. 0.1%
Secondary Endpoint Outcomes: 0.03% vs. 0.1%
Efficacy Conclusions:
Efficacy Conclusions (2):
Potential Risk
Systemic Immunosuppression in Organ Transplant Recipients
Lymphoproliferative Disorder in Adults
Lymphoproliferative Disorder in Children
Time from Initiation of Immunosuppression to Development of Lymphoproliferative Disease
Target Trough Whole Blood Levels of Tacrolimus for Immunosuppression in Transplant Patients
Tacrolimus Blood Levels in Pivotal Controlled Studies
Maximum Tacrolimus Blood Concentrations: -037
Maximum Tacrolimus Blood Concentrations: -035,-036
What accounts for the isolated elevated tacrolimus blood levels?
Clinical Outcome and Blood Levels
Percentage of Patients with Moderate Improvement or Better by Week 1
Blood Levels in a Long-term Study
Persistent Blood Tacrolimus Levels in the One Year Study
Persistent Blood Tacrolimus Levels in the One Year Study
Potential Risk: Topical Vs. Systemic Exposure
Potential Risk: Unresolved Issues
Tacrolimus 0.03% vs. 0.1% ointment: 0.03%
Tacrolimus 0.03% vs. 0.1% ointment: 0.1%
Advisory Committee Question #1
Advisory Committee Question #2
Advisory Committee Question #3
Advisory Committee Question #4
Advisory Committee Question #4
Advisory Committee Question #4
Advisory Committee Question #5
|