New Rapamune dosing guide OKed by FDA

New Jersey, USA-based Wyeth Pharmaceuticals says that the Food and Drug Administration has cleared new dosing recommendations for its immunosuppressant Rapamune (sirolimus). Currently, the drug is used to treat high-risk renal transplant patients.

Wyeth explained that the new usage guidelines stipulate that the agent can be used in combination with cyclosporine (CsA) and corticosteroids in kidney transplant recipients at elevated risk of rejection, including those who have lost a previous transplant due to imunologic events, as well as patients with high-panel reactive antibodies. In addition, the new labeling extends to the use of the product with antibody-induction therapy.

The Madison-heaquartered company said that, in a clinical trial of high immunologic risk patients, survival at one year was 94.6% versus the 84% average survival rate in such subjects not on combination treatment, according to data from the US Organ Procurement and Transplant Network.