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UPDATE 2-U.S. approves Novartis's Tekturna HCT

Mon Jan 21, 2008 4:59am EST

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ZURICH, Jan 21 (Reuters) - U.S. regulators have approved Novartis AG's (NOVN.VX) Tekturna blood-pressure pill in combination with the diuretic hydrochlorothiazide (HCT), the Swiss drugmaker said on Monday. The Food and Drug Administration approved a combination of Tekturna, co-developed by Swiss biotech company Speedel SPPN.S, with HCT in a single tablet.

The approval was widely expected but nevertheless is an important step in realising the full potential of Tekturna, known as Rasilez in Europe and seen as a potential blockbuster drug, Vontobel analyst Karl-Heinz Koch said.

"The approval of Tekturna HCT in the U.S. is important to accelerate the prescription uptake of the drug in the U.S., which so far has been relatively slow due to the simultaneous launch of Exforge, another Novartis blood pressure drug," Koch said in a note.

Novartis shares fell 1.0 percent to 58.15 Swiss francs by 0950 GMT, outperforming the Swiss blue-chip index .SSMI which was 2.4 percent lower. Clinical data has shown Tekturna HCT lowers blood pressure more than either drug alone, Novartis said in a statement. HCT is one of the most commonly used medicines for high blood pressure.

The approval, based on clinical trials involving more than 2,700 patients, was for people not controlled by either medicine alone. (Reporting by Katie Reid and Sam Cage; Editing by Quentin Bryar)



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