Everolimus Approved for Prophylaxis of Organ Rejection in Heart and Kidney Transplants
May 22, 2005, 22:30, Reviewed by: Dr.
|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.
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.
This release contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "will", "positive recommendations", "continuing", or similar expressions, or by express or implied discussions regarding potential additional marketing approvals or future sales of Certican. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause the actual results with Certican to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Certican will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels. Any such results can be affected by, among other things, uncertainties relating to clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general, government, industry, and general public pricing pressures, as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
Eisen HJ et al. Everolimus for the Prevention of Allograft Rejection and Vasculopathy in Cardiac-Transplant Recipients. N Engl J Med 2003; 349: 847-858.
Vitko S et al. Everolimus with Optimized Cyclosporine Dosing in Renal Transplant Recipients: 6-Month Safety and Efficacy of Two Randomized Studies. Am J Transplant 2004; 4: 626-635.
* Certican is indicated for prevention of rejection in adult patients at low to moderate immunological risk receiving an allogenic renal or cardiac transplant. Certican should be used in combination with ciclosporin for microemulsion and corticosteroids. In longterm Certican should be used with a reduced dose of Ciclosporin for microemulsion.
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