Everolimus Approved for Prophylaxis of Organ Rejection in Heart and Kidney Transplants
By Novartis AG
May 22, 2005, 22:30
Certican (everolimus) was recently approved by Swissmedic for the prophylaxis of organ rejection in heart and kidney transplant patients.* This decision not only provides access to an innovative new therapy for Swiss transplant patients, but also supports expanded regulatory submissions in Asia and Europe.
"The positive Swissmedic decision on Certican will not only make this innovative and valuable therapy available to Swiss patients, but will also allow us to start approval procedures in many countries that require home country approval as a prerequisite for local regulatory reviews," said Giacomo Di Nepi, Head of the Transplantation and Immunology Business Unit, Novartis Pharma AG. "This is very positive news for heart and kidney transplant patients in countries throughout the world"
The countries that require Swissmedic approval as a precursor to submission are China, Hong Kong, Malaysia, Sri Lanka, Vietnam, Bahrain, Belarus, Croatia, Iraq, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Morocco, Nigeria, Oman, Pakistan, Palestine, Qatar, Russia, Saudi Arabia, United Arab Emirates, Uzbekistan, Yemen North, Yugoslavia.
Certican 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 continuing the momentum of world-wide approvals.
Certican is a 'proliferation signal inhibitor' that targets the primary causes of allograft dysfunction (also known as chronic rejection) following organ transplantation, including acute rejection and vascular remodelling.
Certican is the first drug in its class to receive an indication for both heart and kidney transplant recipients. Prophylaxis of allograft dysfunction or late graft loss remains a major unmet medical need in transplantation.
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