Novartis announced that the FDA has approved Amturnide (aliskiren, amlodipine, hydrochlorothiazide tablets), a fixed-dose combination therapy for the treatment of hypertension in patients who are not adequately controlled on any two of the following antihypertensive drug classes: direct renin inhibitor, calcium channel blockers, and diuretics. This approval was based on data from a double-blind, active controlled study conducted on 1,181 patients with moderately elevated blood pressure (mean systolic blood pressure [mSBP] 160—179mmHg) or severely elevated blood pressure (mSBP≥ 180mmgHg) that showed Armturnide produced significantly greater reductions in systolic and diastolic blood pressure in both patient populations compared to three dual combination therapies. Armturnide yielded a further mean reduction in systolic blood pressure/diastolic blood pressure of 9.9/6.3mmHg, 7.2/3.6mmgHg, and 6.6/2.6mmHg, respectively, compared to each of the following dual combination therapies: alikskiren/hydrochlorothiazide, amlodipine/hydrochlorothiazide, and aliskiren/amlodipine.

Amturnide will be available as a once-daily tablet containing aliskiren, amlodipine and hydrochlorothiazide in five dosage strengths: 150/5/12.5mg, 300/5/12.5mg, 300/5/25mg, 300/10/12.5mg, 300/10/25mg.

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