3 month delay in US review of Novartis and Speedel's first-in-class BP drug Tekturna

Swiss drug major Novartis says that the US regulatory review period has been extended by up to three months for Tekturna (aliskiren), potentially delaying approval until the end of first-quarter 2007. The agent was submitted earlier in 2006 to become the first in a new class of antihypertensive medicines in over a decade.

The extension will provide the US Food and Drug Administration with time to consider additional clinical data submitted by Novartis in early December, which 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, the firm noted.

Novartis is confident that providing this additional information to the FDA will help secure US approval for the predicted blockbuster, which was developed in collaboration with Swiss biotechnology firm Speedel.