Tekturna was submitted for approval earlier in 2006 to become the first in a new class of high blood pressure medicines for more than a decade. The decision by the US health authorities is the second regulatory delay Novartis has faced this year after the FDA extended its review of the diabetes drug Galvus.
The extension will provide the FDA with time to consider additional clinical data submitted by Novartis in early December. These data come from a study involving 30 healthy volunteers who received Tekturna at the proposed 300mg 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 US. Tekturna was developed in collaboration with biotech firm Speedel.