First Triple Combo With Aliskiren Gets US Approval

Aliskiren/amlodipine/HCTZ combo gains approval by the FDA

December 27, 2010

December 27, 2010 (East Hanover, NJ) — The US FDA has approved for marketing a triple antihypertensive combination therapy containing the direct renin inhibitor, aliskiren, along with the calcium channel blocker amlodipine and the diuretic, hydrochlorothiazide (HCTZ) [1].

This is the first such combination containing a direct renin inhibitor, says Novartis, which will market the product as Amturnide; it is not indicated as initial therapy, rather use must be reserved for those whose blood pressure is not adequately controlled with any of its two components.

Amturnide joins other three-drug combination pills for hypertension approved in the US. These include Exforge HCT (also Novartis)--a three-drug combo of amlodipine, the angiotensin-receptor blocker (ARB) valsartan and HCTZ, cleared last year-- and Tribenzor (Daiichi Sankyo), which combines the ARB olmesartan, amlodipine and HCTZ, which was approved by the FDA in July. The same product has also just been cleared for marketing in Germany [2], its first European country, where it will be known as Sevikar HCT.

Many experts believe these new triple combinations of antihypertensive drugs will help hard-to-treat patients reach their blood-pressure goals, but an American Society of Hypertension position paper [2,3] published earlier this year cautioned that branded combinations are typically more expensive than combining two or three single-drug pills, particularly if the single medications are available as generics.