The USFDA has approved Novartis Zortress as the first drug to prevent organ rejection in adult patients receiving liver transplantation in the US.
The approval was based on positive data from liver transplant study that compared Zortress in combination with reduced-exposure tacrolimus to standard tacrolimus.
Zortress, which is cleared for use in adults subsequent to liver transplantation, binds to mammalian target of rapamycin (mTOR) and acts with calcineurin inhibitors (CNIs) thereby, lessening the probability of CNI exposure.
Novartis division head David Epstein said, "This second indication for Zortress in just three years in the US follows the recent European approval, further underscoring Novartis' continued commitment to bringing much needed treatment options to the transplant community worldwide."
Zortress medication is previously approved by FDA for adult patients receiving kidney transplantation.
Earlier European Health Authorities also cleared the immunosuppressant for adult liver transplant patients under the trade name Certican.
