FDA approves INSPRA, an aldosterone blocker for the treatment of hy...( PEAPACK N.J. (September 30 2002) -- T...),Health

PEAPACK, N.J. (September 30, 2002) -- The U.S. Food and Drug Administration (FDA) granted marketing approval for Pharmacia's INSPRATM (eplerenone tablets), the first agent designed to selectively block aldosterone, for the treatment of high blood pressure. INSPRA is expected to provide treatment benefits in a broad range of patients.

Approximately 50 million, or one in four, adult Americans, have high blood pressure. Of those, 73 percent are not adequately controlled, and are at increased risk of heart attack, stroke, kidney failure, damage to the eyes, heart failure and atherosclerosis. Control of hypertension has remained inadequate despite the availability of several key classes of compounds.

"Hypertension is a complex disease with many factors contributing to the problem," said Goran Ando, M.D., Executive Vice President and President, R&D, Pharmacia Corporation. "For patients and their health care providers who face unique challenges in achieving and maintaining control of their high blood pressure, INSPRA represents an important new treatment option that goes beyond standard therapies in targeting the aldosterone pathway."

Preclinical and clinical studies suggest that aldosterone contributes to the development and progression of hypertension. Hypertension is associated with significant negative cardiovascular outcomes. The hormone aldosterone is a key component within the RAAS (renin angiotensin aldosterone system) and plays a significant role in the body's regulation of the cardiovascular system. INSPRA works with relative selectivity to block aldosterone receptors.

Clinical trials in approximately 3,000 patients demonstrated that INSPRA is effective in lowering high blood pressure, both alone and in combination with other antihypertensive therapies. INSPRA is generally well tolerated. In studies in which INSPRA was compared to placebo, the overall incidence of adverse events was similar to placebo. The mos
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Contact: Karen Sutherland
908-901-8584
MCS
30-Sep-2002

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