FDA Approves Novartis Hypertension Drug

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Swiss pharmaceutical maker Novartis AG said Tuesday it has received U.S. approval for the hypertension drug Tekturna - a potential blockbuster that has shown the ability to lower blood pressure more effectively than common treatments.

Tekturna is the first new type of medicine in more than a decade for treating High Blood Pressure. Approval from the U.S. Food and Drug Administration makes the United States the first country to allow it to be sold.

"Many patients require two or more medicines to control their blood pressure,” said Novartis development chief James Shannon. “As a new treatment approach, Tekturna has the potential to help these patients manage their disease.”

The drug is expected to reach U.S. pharmacies later this month, the company said. It is given in oral tablets and acts by targeting renin - an enzyme responsible for High Blood Pressure.

Novartis shares rose 3.6 percent to 69.25 Swiss francs ($56.90) in Zurich.

Analysts said Tekturna should eventually replace Diovan, Novartis’ best-selling drug with annual sales of $4.2 billion, but whose patent will probably expire in 2012. Novartis submitted Tekturna to European Union authorities last year but is still waiting for approval.

Clinical studies have indicated that Tekturna lowers High Blood Pressure when given on its own, or in combination with current treatments. Patients suffering from High Blood Pressure typically take more than one drug to treat their condition.

Many existing drugs fail to control blood pressure in a sustainable way for longer than a day, causing doctors to often prescribe two doses a day. Studies showed that Tekturna is able to keep blood pressure down for more than 24 hours, reducing the risk of heart attack and stroke.

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