FDA approves Novartis' combo pill Teklamo

The FDA has approved Teklamo, a high blood pressure medication that combines Tekturna with the calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

Tekturna is part of a new class of medicines known as direct renin inhibitors, which target an enzyme responsible for triggering a process that can contribute to high blood pressure. The drug hit the market in 2007 and is poised to gradually replace the company's best-selling drug Diovan, which loses patent protection in 2012. It had sales of $290 million in 2009. 

The Teklamo approval is key in the company's strategy to broaden the use of Tekturna. "This approval reinforces Novartis' commitment to cardiovascular research and to developing innovative and effective treatments for patients who have not reached their blood pressure goal," says David Epstein, division head of Novartis Pharmaceuticals.

- see Novartis' release on the approval
- check out the Reuters story

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