The Swiss regulatory authorities have cleared Novartis’ immunosuppressant drug Certican (everolimus), providing a further regulatory boost for the product that suffered a delay in the US market in 2003, after the US Food and Drug Administration asked for more clinical data [[21/10/03d]].
Since then, Certican has won approval for preventing rejection in heart and kidney transplants in the European Union [[02/12/04d]], and the Swiss approval opens the door to approval in 25 other countries around the world, including China and Hong Kong.
Novartis needs to accelerate the take-up of Certican to support its transplantation franchise, which for years was driven by its Sandimmun and Neoral brands of cyclosporine. In the first quarter of 2005, the franchise suffered a 6% decline in sales as a result of generic competition to the cyclosporine brands.
Last March, Certican was launched in Germany, its first European market, for the prevention of rejection episodes following heart or kidney transplantation. The drug is now approved in over 40 countries and recently was launched in Spain, with additional positive recommendations for approval received in Australia, South Africa and Israel.