Novartis (NVS) recently announced that the US Food and Drug Administration (:FDA) has approved Zortress (everolimus) for an additional indication.
Zortress is now approved for the prophylaxis of organ rejection in adults undergoing a liver transplant.
The approval was based on results from a phase III randomized study, which was conducted in 719 liver transplant patients starting 30 days post-transplant. The study spanned over 12 months.
Zortress reported revenues of $210 million in 2012, up 20% year over year driven by robust demand.
We note that Zortress is already approved in the US for the prophylaxis of organ rejection in adult patients undergoing kidney transplant.
The approval for the new indication makes Zortress the first mTOR inhibitor approved to prevent organ rejection in adult liver transplant patients in the US. We expect that the recent approval will further boost Zortress sales.
We remind investors that everolimus was approved by EU for use in adult liver transplant patients in the fourth quarter of 2012 under the trade name Certican.
Certican is already approved in more than 90 countries namely Chile, Philippines and Argentina to prevent organ rejection for renal and heart transplant patients. In most EU member countries, Certican is also approved in kidney and heart transplantation.
Novartis has also licensed Zortress to Abbott (ABT) and sub-licensed to Boston Scientific for use in drug-eluting stents.
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