Novartis Pharma AG has received an approvable letter from the US FDA for Certican (everolimus) in combination with Neoral (ciclosporin for microemulsion) for the prevention of rejection episodes following heart or kidney transplantation.
According to a company release, the FDA has requested that Novartis provide "additional" information supporting a safe and effective dosing regimen for the combination of everolimus and ciclosporin. The FDA had previously issued an approvable letter for Certican in October 2003 with a request for additional clinical data on dosing regimens. Novartis submitted data in response to the first approvable letter in February 2004. However, the FDA still believes that additional clinical studies on dosing are necessary.
"Everolimus has been shown in clinical trials to provide important benefits that would be of significant value to transplant patients and their health care providers," said Howard Eisen, professor of Medicine at Temple University School of Medicine in Philadelphia.
Already approved for use in Europe, Certican is a novel proliferation signal inhibitor with immunosuppressive and antiproliferative properties. It is the latest innovation in the 20-year history of Novartis leadership in transplantation medication. The new drug application to the FDA for Certican included data from one of the most extensive drug development programmes conducted to date for a transplantation product, the release added.