FDA issues approvable letter for Certican(reg) for transplant rejection

Main Category: Transplants / Organ Donations
Article Date: 30 Aug 2004 - 12:00 PDT


Novartis Pharma AG has received an "approvable" letter from the US Food and Drug Administration (FDA) for Certican (everolimus) in combination with Neoral (ciclosporin for microemulsion) for the prevention of rejection episodes following heart or kidney transplantation.

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.

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 programs conducted to date for a transplantation product.

"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, M.D., Professor of Medicine at Temple University School of Medicine in Philadelphia.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Novartis Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland. Novartis Group companies employ about 80,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

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Contacts

Eric Althoff
Novartis Pharma Communications
Tel + 41 61 324 6392
or +41 61 324 2200
eric.althoff@pharma.novartis.com

John Gilardi
Novartis Global Media Relations
Tel +41 61 324 3018
or +41 61 324 2200
john.gilardi@group.novartis.com

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