REGULATORY NEWS

Novartis scores FDA OK for combo blood pressure drug


The FDA has approved Tekturna HCT (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Tekturna HCT is a single-pill combination of Tekturna (aliskiren), a direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ), a common high blood pressure medication.

The approval of Tekturna HCT as initial therapy was based on clinical trial data involving more than 2,700 patients, which showed that treatment with the combination of Tekturna and HCTZ offered greater blood pressure reductions than either drug alone, according to the East Hanover, N.J.-based Novartis.

Tekturna was approved in the U.S. in 2007 as the first direct renin inhibitor. In 2008, Tekturna HCT was approved in the U.S. for a second-line treatment of high blood pressure. The long-term potential of Tekturna is being studied in a clinical program, including outcomes trials, known as ASPIRE HIGHER.

Novartis said that Tekturna HCT is available in four strengths as tablets containing aliskiren and hydrochlorothiazide: 150 mg/12.5 mg tablets, 150 mg/25 mg tablets, 300 mg/12.5 mg tablets and 300 mg/25 mg tablets.

In July 2008, Novartis purchased the remaining shares of Tekturna from Speedel Holding through a public tender offer of approximately $980 million.
Last updated on July 22, 2009 at 8:06 am EST