FDA Clears Novartis’ Amturnide Triple Combination Hypertension Drug

(GenENGNews.com) — FDA has approved Novartis’ Amturnide™ triple combination pill for the treatment of hypertension in patients whose blood pressure remains uncontrolled when taking two of the new drug’s individual components. Amturnide combines Novartis’ direct rennin inhibitor Tekturna®/Rasilez® (aliskiren), with the calcium channel blocker amlodipine and the diuretic hydrochlorothiazide.

FDA clearance of Amturnide is based on data  from a 1,181 patient trial, which showed that Amturnide reduced blood pressure to a greater degree than any dual combination of its three active ingredients. The triple combination was submitted to the European regulatory authorities in May 2010.

In August FDA approved Tekamlo, a single-pill combination of Tekturna and amlopidine. Review of this combination is ongoing by the European authorities, and an opinion by the human medicinal products committee is expected during the first quarter of 2011.


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