Another approval for Novartis’ everolimus
pharmafile | February 18, 2013 | News story | Sales and Marketing |Â Â Certican, Novartis, Zortress, everolimusÂ
Novartis has gained US approval for its drug Zortress (everolimus) to prevent liver transplant rejection.
Zotress is already used to prevent rejection of kidney transplants, and the new approval is just the latest in a string of licences for the active ingredient, everolimus.
The drug was first approved in 2009 to treat advanced kidney cancer, but Novartis has successfully pursued many other licensed indications in treating cancer and transplant rejection.
The full list of everolimus approvals (shown with relevant brand name)
- Advanced renal cell carcinoma (approved March 2009) Afinitor
- Prevention of organ rejection after renal transplant (April 2010) Certican/Zortress
- Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) in patients who are not suitable for surgical intervention (October 2010) Votubia
- Progressive/metastatic pancreatic neuroendocrine tumours not surgically removable (May 2011) Afinitor
- Breast cancer in post-menopausal women with advanced hormone-receptor positive, HER2-negative type cancer, in conjunction with exemestane (July 2012) Afinitor
Zortress is the first immunosuppressant to gain US approval in over a decade for use following liver transplantation.
Phase III trials shows that the drug can help prevent or limit chronic renal failure in patients taking standard anti-rejection drugs such as tacrolimus.
Chronic renal failure is a bigger problem in liver transplant recipients than in any other solid organ transplants, except intestinal transplants. Calcineurin inhibitors (CNIs), such as tacrolimus, are standard treatment for liver transplant patients but can impair renal function.
Zortress works by binding to a protein called mTOR, and acts synergistically with CNIs, offering an opportunity to lower the dose of CNI drugs.
The approval was based on the largest liver transplant study to date, which showed that Zortress plus reduced tacrolimus led to comparable efficacy and 10mL/min higher renal function as measured by estimated glomerular filtration rate (eGFR) for Zortress compared to standard tacrolimus at 12 months.
European Health Authorities approved Certican (everolimus) for the prophylaxis of organ rejection in adult patients receiving a liver transplant in the fourth quarter of 2012. In most EU member countries, Certican is also approved in kidney and heart transplantation.
Zortress plus reduced-exposure tacrolimus
The US approval was based on 12-month results from a Phase III trial conducted in 719 liver transplant patients starting 30 days post-transplant.
Patients were randomised to one of three groups: Zortress plus reduced-exposure tacrolimus, Zortress followed by tacrolimus withdrawal at four months or standard-exposure tacrolimus only.
However it quickly became clear that the withdrawal of tacrolimus was not a viable option, as there were a higher level of acute rejection episodes and adverse reactions, and recruitment to this trial arm was halted.
Andrew McConaghie
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