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U.S. Approves Novartis Hypertension Drug 2007-03-07
By NY Times

U.S. Approves Novartis Hypertension Drug

The Swiss pharmaceutical maker Novartis said Tuesday that it had received United States approval for the hypertension drug Tekturna, a potential blockbuster that is the first new type of blood pressure medicine in more than a decade.

Approval from the Food and Drug Administration makes the United States the first country to allow it to be sold.

The drug is expected to reach American pharmacies later this month, the company said. Given in tablets, it acts by inhibiting renin, an enzyme secreted primarily by the kidneys that raises blood pressure.

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

Novartis shares were up $3.31, or 6 percent, to $56.85, on the New York Stock Exchange. Analysts said Tekturna should eventually replace the blood pressure drug Diovan, Novartis's best-selling drug with annual sales of $4.2 billion, whose patent will probably expire in 2012. Novartis submitted Tekturna to European Union authorities last year but is still waiting for approval.

Many existing drugs fail to control blood pressure in a sustainable way for longer than a day, leading doctors to 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.


 
 
 
Patent Pending:   60/481641
 
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