Rapamune transplant drug approved in Canada

Wyeth-Ayerst Canada has received approval from Health Canada forRapamune (sirolimus) for the prevention of organ rejection following renal transplantation.

Rapamune, an immunosuppressant which is recommended for use in combination with cyclosporine and corticosteroids, was shown in clinical trials to reduce acute rejection rates in kidney transplant patients by up to 60% compared to control regimens, which contained cyclosporine and corticosteroids in combination with either azathioprine or placebo. Graft loss and patient survival rates were similar in the Rapamune- and comparator-treated groups at six and 12 months, and the study also showed that Rapammune caused a reduction in the incidence of all grades of acute rejection episodes.

Allan MacDonald, director of transplantation at the QEII Health Sciences Center, Nova Scotia, said that although kidney transplant patients can expect to live with their new kidney for one to two decades, "an important consideration is that the drugs they need to take in order to prevent rejection can produce side effects that are difficult to tolerate, physically and emotionally." He notes that offering patients Rapamune, which has a reduced side effect profile, can significantly improve their long-term quality of life.