The FDA has approved Zortress (everolimus tablets, from Novartis) for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and corticosteroids. This approval was based on data from a Phase 3 registration study in kidney transplant patients. Zortress was shown to prevent acute organ rejection and preserve kidney function while allowing, on average, 60% lower doses of cyclosporine to be used compared with the control regimen of mycophenolic acid (MPA) with full dose cyclosporine and corticosteroids.
Zortress will be available in 0.25mg, 0.5mg, and 0.75mg dosage strengths.
For more information call (800) 693-9993 or visit www.pharma.us.novartis.com.