Novartis nabs another FDA-approved indication for everolimus

Zortress nabbed another approval.--Courtesy of WebMD

Turns out, everolimus is becoming quite the franchise for Novartis ($NVS). Sold under the Afinitor and Votubia names for tumor treatment and as Zortress and Certican for transplant patients, everolimus is one of the Swiss drugmaker's lead drugs in the post-Diovan era. And it just nabbed another approval, this time as Zortress, to prevent organ rejection in liver transplant patients.

The liver-transplant indication isn't nearly as lucrative as Afinitor's recent nod for breast cancer, which could eventually add $1 billion to $1.5 billion to the drug's annual sales. Right now, Afinitor brought in about $800 million last year--an increase of 85%--while the Zortress and Certican brands accounted for about $210 million, a 20% rise.

That $210 million in 2012 sales on the transplant side derived from approvals in heart and kidney transplant patients. There are more than 15,000 kidney transplants in the U.S. each year, and about 6,000 liver transplants annually, the National Institutes of Health says.

The strength of Zortress in liver transplants lies not only on the efficacy side, but in safety. Studies suggest that the drug, an mTOR inhibitor, triggers fewer kidney problems than older drugs known as calcineurin inhibitors. The drug won approval for liver transplant patients in Europe late last year under the Certican name.

- get the release from Novartis
- read the PM Live story