Novartis Blood Pressure Drug Approved in US
Posted on: Tuesday, 6 March 2007, 12:01 CST
Novartis has said that the US has approved Tekturna tablets, the first new type of medicine in more than a decade for treating high blood pressure.
The Food and Drug Administration issued the approval for Tekturna as the first in a new class of drugs called direct renin inhibitors. A once-daily oral therapy, Tekturna acts by targeting renin - an enzyme responsible for triggering a process that can contribute to high blood pressure.
Tekturna received FDA approval for treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. The use of Tekturna with maximal doses of ACE inhibitors has not been adequately studied. Tekturna is expected to be available in March as 150mg and 300mg tablets.
"Renin angiotensin system activity contributes to many of the complications associated with high blood pressure," said Marc Pfeffer, professor of Medicine, Harvard Medical School and Cardiologist, at Brigham & Women's Hospital.
"By inhibiting this important system at its origin, renin production, a direct renin inhibitor, such as Tekturna, offers an exciting therapeutic option for treating hypertension."
In an extensive clinical trial program, Tekturna provided significant blood pressure reductions for a full 24 hours. Furthermore, Tekturna provided added efficacy when used in combination with other commonly used blood pressure medications.
Novartis said it is committed to conducting a large outcome trial program to evaluate the long-term effects of Tekturna and direct renin inhibition. Tekturna was developed in collaboration with Speedel.
Source: Datamonitor
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