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| |  Diovan For First-Line Treatment of Hypertension Cleared by FDA SUMMIT, N.J., Dec. 26, 1996 -- Ciba Pharmaceuticals today announced that it has received marketing clearance from the U.S. Food and Drug Administration for Diovan(TM) (valsartan), the newest entry to a novel class of antihypertensive drugs, the angiotensin II receptor blockers (ARBs). Diovan is indicated for the first-line treatment of hypertension. It offers blood pressure control comparable to current leading antihypertensive therapies (lisinopril and enalapril) and an outstanding side-effect profile. Diovan will be the first new chemical entity introduced by the newly formed Novartis Pharmaceuticals Corporation and will be available by the second quarter of 1997. Novartis is the second largest pharmaceutical business in the world, formed by the recently approved merger of Ciba and Sandoz. "With Diovan, the patient does not have to sacrifice efficacy for safety," said Malcom MacNab, M.D., Ph.D., vice president, cardiovascular development, Ciba. "Clinical trials involving more than 5,500 patients have shown Diovan to be as effective in controlling high blood pressure as today's leading treatments for hypertension, lisinopril and enalapril." Dr. MacNab continued, "Diovan is an important addition to current high blood pressure therapy because the overall incidence of adverse events with Diovan is similar to placebo, avoiding the side effects associated with established drug classes such as ACE inhibitors and calcium channel blockers. Considering the consequences associated with untreated hypertension, Diovan is an improvement for patients concerned about taking high blood pressure medication because of adverse side effects. Thus, Diovan is ideal for newly diagnosed hypertensive patients and for those patients who have experienced negative side effects from their current medications." Diovan works by selectively blocking the angiotensin II hormone from binding to the AT1-receptor, located in many different tissues such as vascular smooth muscle. The blocking of angiotensin II results in dilation of blood vessels, thereby lowering blood pressure. Diovan is a first-line therapy which has a recommended starting dose of 80 mg once daily and will be available by prescription in capsule form. As with other drugs that work in the renin-angiotensin system, Diovan therapy should be discontinued as soon as pregnancy is detected. Full prescribing information about Diovan is available from the manufacturer. Ciba Pharmaceuticals is a division of Ciba-Geigy Corporation of Tarrytown, N.Y., a wholly owned subsidiary of Ciba-Geigy Limited of Basel, Switzerland. On December 17, 1996, Ciba and Sandoz received provisional approval by the U.S. Federal Trade Commission to form Novartis. The merger will take effect in the United States on January 1, 1997.
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