An advisory subcommittee has recommended that the Food and Drug Administration (FDA) approve Rapamune (sirolimus) for the prevention of acute kidney rejection following transplantation.
"If final approval is ultimately given by the FDA, Rapamune would be the first of a new class of immunosuppressive agents developed to treat transplant patients," said American Home Products, whose pharmaceutical division, Wyeth-Ayerst Laboratories, makes Rapamune. Unlike other transplant drugs, Rapamune does not inhibit calcineurin.
The Subcommittee of the Antiviral Drugs Advisory Committee on Immunosuppressive Drugs voted on July 27 to recommend the approval of Rapamune, which has been granted priority review status by the FDA. Although the subcommittee's recommendations are not binding, the FDA usually follows them.
In its application, Wyeth-Ayerst presented data from two large studies evaluating the efficacy and safety of the drug. More than 700 recipients of kidney transplants participated in a randomized, double-blind, comparative, race-stratified study at 38 centers in the United States. Rapamune also was evaluated in more than 550 patients in a placebo-controlled, randomized, double-blind study conducted at more than 40 centers in nine countries.
For Your Information:
American Home Produces press release
www.ahp.com/releases/ahp_072799.htmTransplant News Network, June 1, 1999
"Studies Show Rapamune's Potential as Immunosuppressive Drug"
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