New Transplant Drug Certican® Gets First Approval in Europe

The Swedish Medical Products Agency has granted marketing authorization for Novartis’ new immunosuppressant drug Certican® (everolimus) for use in kidney and heart transplantation, according to the drug's manufacturer.

Certican is a novel proliferation signal inhibitor that targets the primary causes of chronic organ rejection, including acute rejection, and cytomegalovirus infection.

Novartis applied for U.S. Food and Drug Administration approval of Certican in late 2002.

At that time, the company said clinical studies that have followed more than 1,500 heart and kidney transplant recipients for up to 36 months showed that Certican, when used with cyclosporine and steroids, effectively helped prevent organ rejection.

Other Sources: Novartis