By Mark Chael

Novartis announced today that the U.S. Food and Drug Administration approved the use of Tekturna® (aliskiren) for the treatment of high blood pressure as a single therapy or in combination with other high blood pressure medications.  Apparently, the FDA had previously indicated that it would need more time to review the Tekturna® new drug application (NDA); causing some to speculate that the drug would not be approved or that the approval would be limited.  Novartis developed Tekturna® in collaboration with Speedel, a biopharmaceutical company specializing in cardiovascular and metabolic diseases.

It is estimated that high blood pressure occurs in almost one billion people worldwide and is not adequately controlled in about 70% of those affected.  Tekturna® (aliskiren) is the first in a new class of drugs called "direct renin inhibitors."  Renin is a circulating enzyme involved in the biochemical pathway that regulates blood volume, sodium chloride concentrations in the blood, and blood pressure.  More information about renin can be found here.

Novartis says that Tekturna® will be available this month in once-daily oral tablets at 150 mg and 300 mg dose strengths.  Also, Tekturna® is under review in the European Medicines Agency for approval throughout the European Union, where it will be called Rasilez® if approved.

Additional information regarding the FDA’s approval of Tekturna® (aliskiren) for the treatment of high blood pressure can be found here.