BASEL (dpa-AFX) - Swiss drug maker Novartis AG (NVS), said Friday the U.S. Food and Drug Administration has approved Zortress as the first immunosuppressant in a decade to prevent organ rejection in adult liver transplant patients.
The approval also means that Zortress (everolimus) is the first mammalian target of rapamycin (mTOR) inhibitor to prevent organ rejection in adult liver transplant patients in the US.
The approval was based on positive outcomes from the largest liver transplant study ever, comparing Zortress plus reduced-exposure tacrolimus to standard tacrolimus.
Calcineurin inhibitors (CNIs) such as tacrolimus are part of the standard treatment for immunosuppression in liver transplantation, but they can contribute to adverse events such as impaired renal function. Zortress works by binding to a protein called mTOR, and acts synergistically with CNIs, offering an opportunity to lower CNI exposure.
The US approval for Zortress was based on 12-month results from a Phase III, open-label, randomized, controlled study conducted in 719 liver transplant patients starting 30 days post-transplant.
In the study, during the first 30 days after transplant and prior to randomization, patients received tacrolimus and corticosteroids, with or without mycophenolate mofetil. No induction antibody was administered.
Thirty days following liver transplantation, patients were randomized to one of three groups: Zortress plus reduced-exposure tacrolimus, Zortress followed by tacrolimus withdrawal at four months or standard-exposure tacrolimus only.
Results showed that the incidence of efficacy failure was lower in the Zortress plus reduced-exposure tacrolimus group compared to the tacrolimus control group at month 12.
In the US, Zortress was earlier approved for the prevention of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant.
Everolimus is one of the most-extensively studied immunosuppressants in solid organ transplantation with more than 10,000 transplant recipients enrolled in Novartis-sponsored clinical trials.
Under the trade name Certican, it is approved in more than 90 countries to prevent organ rejection for renal and heart transplant patients, and in addition, is approved in the EU and other countries worldwide to prevent organ rejection for liver transplant patients.
Novartis closed Friday at $69.20, up 0.76%, on a volume of 0.9 million shares on the NYSE.
On the Swiss exchange, Novartis closed at 63.90 francs, up 1.11%, on a volume of 14.7 million shares.
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