Supercautious FDA delays Aliskerin Approval

A while ago, I posted that at the September meeting of the WCC/ESC in Barcelona, Novartis presented their clinical results on about 8,000 patients with hypertension, who were treated with Aliskerin, a Renin inhibitor (a new group of anti-hypertensives) which acts at the renin end of the RAAS system. The results were impressive showing that aliskerin is an effective anti-hyprtensive, which was safe with low incidence of side-effects.

On the basis of that data, Novartis was confident of FDA approval, hopefully by early or mid-2007. Well, this is not to be. Novartis has just submitted additional animal data to FDA showing that Aliskerin may be associated with a small incidence of colonic or gastric mucosal irritation. Therefore more human volunteer studies may have to be done, so the FDA approval will be delayed.

I can't help but think that vioxx has something to do with this. Post-viooxx FDA is supercautious, so as not to make anymore approval blunders. The manufacturers are also supertransparent, submitting data especially if they pertain to safety, so that there can be no future challenge. What ever it is, this is good for patient care, especially with non-critical drug like Aliskerin (there are many other effective choices in hypertension treatment). Whatever it is, Aliskerin and Novartis will have to wait. Maybe this is better then having to face lawsuits and payouts.