Novartis says New Drug Application for blood pressure drug Exforge accepted for review by FDA

By E. Janene Geiss

Philadelphia, April 27 - Novartis AG said Thursday that the New Drug Application for Exforge (amlodipine besylate/valsartan) was accepted for standard review by the Food and Drug Administration as a new treatment option for people with high blood pressure.

The submission for E.U. approval was completed earlier in 2006, according to a company news release.

In clinical trials, Exforge demonstrated clinically significant blood pressure reductions, officials said.

The drug uses two complementary mechanisms of action through the calcium channel blocker amlodipine and the angiotensin receptor blocker valsartan. Both agents are the No. 1 prescribed branded medications in their respective classes, officials said.

The U.S. filing was based on a clinical trial program involving more than 5,000 hypertensive patients. The program included five controlled trials in which more than 2,600 patients received Exforge once daily, officials said.

A single daily dose of Exforge provided clinically significant blood pressure reductions and was well-tolerated.

Novartis Pharmaceuticals Corp., based in East Hanover, N.J., develops, manufactures and markets leading prescription drugs used to diseases. It is an affiliate of Novartis AG, a Basel, Switzerland, health care products company.

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