The Food and Drug Administration (FDA) has approved Rapamune (sirolimus) for the prevention of organ rejection after kidney transplantation.
The approval came about seven months after the FDA granted priority review status to the drug, which is the first drug in a new class of immunosuppressants. Instead of inhibiting calcineurin, as the immunosuppressants cyclosporine and tacrolimus do, Rapamune inhibits the activation of TOR (target of rapamycin), a regulatory kinase involved in cell cycle progression.
Clinical trials have shown that Rapamune, used in combination with cyclosporine and corticosteroids, reduces acute rejection rates by up to 60% compared to controls, said American Home Products (www.ahp.com/releases/ahp_091599b.htm). Rapamune is made by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products.
"Rapamune represents a new alternative in immunosuppression. It will provide an important new treatment option for renal transplant patients, which is especially significant since there aren't many therapeutic choices," said Barry D. Kahan, PhD, MD, of the University of Texas – Houston Health Science Center, who has been studying Rapamune. Recent findings regarding Rapamune were reported by Transplant News Network on June 1, 1999.
In other regulatory news, on September 21 the FDA approved Synercid, the first injectable drug in the streptogramin class of antibiotics (www.rp-rorer.com/ABOUT_RPR/pressrels/1999/990921-synercid.html). A product of Rhone-Poulenc Rorer Pharmaceuticals, Synercid is approved for the treatment of bloodstream infections due to vancomycin-resistant Enterococcus faecium and for skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes. Synercid is approved for use in life-threatening conditions when other therapies are not available. Synercid was approved in the United Kingdom in August.
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