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

  1. 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?
  1. 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?
  2. If the answer is no, what additional information would be needed to support such a maintenance regimen?
  1. .What additional Phase 4 studies would you recommend?
  2. 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.