Send to printer »

GEN News Highlights : Dec 23, 2010

FDA Clears Novartis’ Amturnide Triple Combination Hypertension Drug

Single pill comprises aliskiren, amlodipine, and hydrochlorothiazide.

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.

Tekturna itself is Novartis’ 17th best-selling pharmaceutical product, and generated sales of $113 million during the third quarter of 2010, up 42% in constant currency compared with the equivalent period 2009. Tekturna sales for the first nine months of 2010 were up 53%, at $305 million.

Novartis’ top-selling drug is another hypertension therapy, Diovan/Co-Diovan, which achieved global sales of $4.47 billion in the first nine months of 2010, albeit a rise of just 2% in constant currency. Another blood pressure treatment, Exforge, is 8th on the Novartis best-seller list, with global nine month 2010 sales of $653 million, up 37%.