Regulatory

US FDA okays everolimus to prevent liver transplant rejection

Last Updated: 2013-02-18 19:30:07 -0400 (Reuters Health)

(Reuters) - U.S. regulators approved Novartis AG's Zortress as the first new drug in more than a decade for preventing organ rejection in adult liver transplant recipients, the company said on Friday.

The drug, also known as everolimus, is already approved by the Food and Drug Administration for preventing kidney graft rejection.

Regulators in Europe, where the drug is known as Certican, approved the liver transplant indication last October. The drug is sold in more than 90 countries to prevent organ rejection for renal and heart transplant patients, Novartis said.

Everolimus is also sold in different dosage strengths for uses in non-transplant patients under the brand names Afinitor and Votubia.