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US approves Novartis drug for treating hypertension

BASEL, Switzerland -- Swiss pharmaceutical maker Novartis AG said yesterday it has received US 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 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 US pharmacies this month, the company said. It is given in oral tablets and acts by targeting renin -- an enzyme responsible for high blood pressure.

"Today's approval adds a new, safe, and effective treatment option for people who need help to control their blood pressure," said Douglas C. Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research.

The decision was a relief for Novartis after the FDA last month asked for additional data on its other potential blockbuster drug, diabetes treatment Galvus. This means a delay of around 18 months for that drug and some analysts had feared the agency's focus on safety when deciding on new drug approvals could also lead to a delay in Tekturna.

Novartis shares closed up 4.9 percent to $57.56.

Analysts said Tekturna should eventually replace Diovan, Novartis' best-selling drug, but whose patent will probably expire in 2012. Novartis submitted Tekturna to the European Union last year but is still waiting for approval.