FDA Approves Higher Dose Formulations of Diovan HCT

FDA Approves Higher Dose Formulations of Diovan HCT for Treatment of High Blood Pressure

EAST HANOVER, N.J., May 1, 2006 -- The U.S. Food and Drug Administration (FDA) approved two new, higher dose formulations of the high blood pressure medication Diovan HCT (valsartan/hydrochlorothiazide): 320/12.5 mg and 320/25 mg. The approval of the higher strengths of Diovan HCT provides more options to help physicians more effectively manage their patients' high blood pressure. The new formulations of Diovan HCT will be commercially available by early June 2006.

Diovan HCT is a combination of the efficacious blood pressure medicine Diovan (valsartan), the most prescribed agent in the ARB (angiotensin receptor blocker) class, and the diuretic hydrochlorothiazide (HCTZ). The majority of high blood pressure patients will require a combination of two therapies, like Diovan HCT, to achieve blood pressure goals. Diovan HCT provides greater blood pressure-lowering benefits to patients who require more than either the diuretic or Diovan alone. Previously, Diovan HCT was available in 80/12.5 mg, 160/12.5 mg, and 160/25 mg tablets.

"Millions of patients already rely on Diovan and Diovan HCT to help them get to goal and maintain healthier blood pressure levels," said Alex Gorsky, head of pharma, North America and chief executive officer, Novartis Pharmaceuticals Corporation. "The approval and availability of these new formulations means that, with Diovan HCT, physicians will have the widest and most flexible range of dosing options in the ARB class."

High blood pressure is a public health crisis, affecting more than 65 million Americans or one in three adults. The risk of cardiovascular disease doubles with every increase of 20/10 mmHg above a healthy blood pressure of 115/75 mmHg. High blood pressure medications not only lower blood pressure, but also reduce the risk of suffering a stroke or heart attack. Overall 70 percent of people with high blood pressure do not have their condition controlled. Moreover, about half of those taking medication for their condition do not have it successfully managed, underscoring the need for more powerful treatments.

Details of Data Supporting Approval

Data supporting approval showed the new higher doses of Diovan HCT provided significantly greater reductions in blood pressure compared to either therapy alone. Diovan HCT 320/25 mg lowered systolic/diastolic blood pressure 25/17 mmHg compared to 6/7 mmHg with placebo alone.

The blood-pressure lowering effect of the high doses of Diovan HCT was maintained throughout long-term follow-up studies lasting up to one year (without placebo control), and was the same regardless of age or gender, and for black and non-black patients.

The overall incidence of adverse events with Diovan HCT was comparable to placebo. Further, giving Diovan in combination with HCTZ lowered the incidence of hypokalemia (low blood potassium) associated with HCTZ. Hypokalemia can cause cardiac arrhythmia, muscle pain and/or weakness, general discomfort, irritability, extreme thirst, frequent urination and confusion.

Data To Be Presented At ASH

Much of the data supporting approval of the higher dose formulations of Diovan HCT will be presented at the upcoming American Society of Hypertension, Inc. (ASH) Annual Scientific Meeting and Exposition May 16-20, 2006, in New York, NY. In total, more than 30 studies related to Diovan, Diovan HCT and other Novartis medications for treating high blood pressure will be presented. The presentations will include clinical data on the efficacy of Rasilez (aliskiren) and Exforge (amlodipine besylate/valsartan), both investigational agents for which Novartis recently submitted new drug applications to the FDA for their use in treating high blood pressure.

"The breadth and depth of data to be presented at ASH underscore Novartis' innovation and leadership in the hypertension category," Mr. Gorsky added. "We continue to strongly support a robust research program to fully develop Diovan and Diovan HCT, as well as investigate new therapies such as Rasilez and Exforge."

About Diovan and Diovan HCT

Diovan and Diovan HCT should be discontinued as soon as pregnancy is detected because it may cause harm or even death to the unborn child. If you get pregnant or plan to get pregnant, call your doctor right away.

Do not take Diovan or Diovan HCT if you are allergic to any of the ingredients in these products.

Do not take Diovan HCT if you have a history of reduced urine output, or have allergic reactions to certain drugs known as sulfonamides. If you're taking Diovan HCT, tell your doctor about all your medical conditions and medicines you take, including: liver or kidney problems, lupus or if you take lithium.

In clinical studies with Diovan and Diovan HCT, side effects have generally been mild. The most serious side effects with both Diovan and Diovan HCT are low blood pressure (hypotension) and kidney problems, and additionally with Diovan HCT, skin rash. The only side effect that was more frequent with Diovan HCT than placebo was nasopharyngitis (2.4% vs 1%). In individual studies, a dose-related increase in the incidence of dizziness was observed Diovan HCT-treated patients.

Diovan HCT is not for the initial treatment of high blood pressure. Diovan HCT may be the right medication for you if Diovan or certain other blood pressure medicines alone have not worked.

Source: Novartis

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