FDA EXTENDS REVIEW PERIOD OF NOVARTIS' TEKTURNA NDA

Novartis announced today that the FDA review period has been extended by up to three months for the new drug application (NDA) for Tekturna (aliskiren), which was submitted for approval earlier in 2006 to become the first in a new class of blood pressure medicines for in than a decade.

The extension will provide the FDA with time to consider additional clinical data submitted by Novartis earlier this month. These data come from a study involving 30 healthy volunteers who received Tekturna at the proposed 300-mg once-daily dose for eight weeks to study potential changes of the colonic mucosa. Analysis of the data indicated that Tekturna did not induce any changes in the mucosal lining of the colon, as evaluated by colonoscopy and biopsies.

Novartis is confident that providing this additional information to the FDA will help secure approval for Tekturna in the U.S. and allow for this important therapy to be offered to patients seeking to control high blood pressure. Tekturna was developed in collaboration with Speedel.