FDA gives nod to Novartis' hypertension drug

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The FDA has approved Novartis’ blood pressure pill Tekamlo, a combination of aliskiren (Tekturna) and channel-blocker amlodipine, for use as a replacement therapy for patients who cannot control hypertension with either aliskiren or amlodipine alone or who need multiple drugs to achieve optimal blood pressure results.

According to the East Hanover, N.J.-based company, the FDA's approval was based on the results of a double-blind, placebo-controlled clinical trial involving more than 5,000 patients with mild-to-moderate blood pressure who were administered Tekamlo and placebo.

After an eight-week follow-up, researchers found that the combination of Tekturna and amlodipine lowered patients’ systolic/diastolic blood pressure better than use of either Tekturna or amlodipine alone, Novartis reported.