FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING
SUBCOMMITTEE FOR IMMUNOSUPPRESSANTS
TENTATIVE QUESTIONS FOR THE SUBCOMMITTEE
January 24, 2002
Gaithersburg Holiday Inn
Two Montgomery Village Avenue
Gaithersburg, MD 20879
- Do the data presented support the effectiveness and safety of cyclosporine withdrawal 2 to 4 months after kidney transplantation, in patients treated initially with a regimen of sirolimus, cyclosporine and corticosteroids?
- If the answer is yes, should this consideration be restricted to a particular subpopulation? Conversely, is there a particular subpopulation for which cyclosporine withdrawal should not be considered?
- If the answer is no, what additional information would be needed to support such a maintenance regimen?
- .What additional Phase 4 studies would you recommend?
- Do you have any additional comments or recommendations regarding study design and/or endpoints for controlled clinical trials intended to support the safety and efficacy of maintenance immunosuppressive regimens in renal transplantation?
Note: These are tentative questions that may change before or at the time of the meeting.