FDA Approves Everolimus for Liver Rejection

FDA Approves Everolimus for Liver Rejection

By John Gever, Senior Editor, MedPage Today

Published: February 18, 2013

Everolimus (Zortress) has won FDA approval to prevent liver transplant rejection in adults, adding to its earlier similar approval in kidney transplant, according to the drug's manufacturer, Novartis.
The approval is the first for an mTOR inhibitor in liver transplant, the company said.
Clinical data in a 719-patient randomized trial showed that everolimus plus reduced-dose tacrolimus was equivalent in efficacy to conventional tacrolimus, the current standard of care, according to Novartis.

A composite endpoint representing different types of treatment failure -- graft loss, death, or biopsy-proven acute rejection -- as well as loss to follow-up was met by 9% of the everolimus combination group versus 13.6% of the group receiving standard-dose tacrolimus, according to Novartis.
Also, the everolimus combination appeared less renotoxic, with mean estimated glomerular filtration rate higher by 10.6 mL/min/1.73 m² after one year compared with standard tacrolimus (80.9 versus 70.3 mL/min/1.73 m²).

Novartis noted that a registry study had found that liver transplant recipients were at relatively high risk for chronic renal failure, at least in part because of the anti-rejection drugs.

Despite the similarity in generic names, everolimus and tacrolimus are in different drug classes. Whereas everolimus is an mTOR inhibitor (similar to sirolimus, also known as rapamycin and sold as Rapamune), tacrolimus is a calcineurin inhibitor.