Tuesday, August 31, 2004

NOVARTIS RECEIVES APPROVABLE LETTER FROM FDA FOR CERTICAN

Novartis Pharma AG received an approvable letter from the Food and Drug Administration for pharmaceutical brand Certican (everolimus), which is to be used in combination with Novartis' Neoral (cyclosporine) Modified for preventing rejection episodes following heart or kidney transplantation.

In the letter, the FDA requested that Novartis provide further data to support the safety and efficacy of the Certican-Neoral dosing regimen.

In October, the FDA sent a similar approvable letter to Novartis for Certican that also requested the submission of additional information to support the therapy's safety and efficacy in the combined regimen. The company submitted its response to the regulatory agency in February, but the FDA said additional clinical studies on dosing are necessary, according to a Novartis press release.

"[Certican] 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 Dr. Howard Eisen, professor of medicine at Temple University's school of medicine in Philadelphia.

The treatment is already approved for use in Europe.