Thanks Michael.
It will be base to compare this year bios performance.
Tuesday February 5, 8:08 am Eastern Time
Press Release
SOURCE: Pharmacia Corporation
FDA Accepts for Filing Pharmacia's New Drug Application for Eplerenone, a Selective Aldosterone Blocker
Global Clinical Trials Show Eplerenone Provides Benefit in the Treatment of Hypertension
PEAPACK, N.J., Feb. 5 /PRNewswire-FirstCall/ -- Pharmacia Corporation (NYSE: PHA - news) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for eplerenone for the treatment of hypertension (high blood pressure).
Eplerenone, a selective aldosterone blocker (SAB), is being developed as a once-daily, oral therapy designed to specifically block the effects of the hormone aldosterone. 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.
The hypertension NDA includes clinical studies involving more than 3,000 hypertensive patients. Key results include efficacy in blood pressure reduction across multiple patient populations, including African Americans, the elderly, diabetics and systolic hypertensives. Eplerenone has been studied both alone and in combination with other classes of antihypertensive agents.
Recent understanding of the role of aldosterone has expanded greatly and there is now preliminary evidence from preclinical and clinical studies suggesting that aldosterone contributes to the development and progression of hypertension and heart failure, including damage to blood vessels, the kidney and the heart.
``Despite many medical advances, hypertension remains poorly controlled and millions of patients are taking more than one medication in an attempt to control their blood pressure,'' said Carrie Cox, Executive Vice President and President, Global Prescription Business, Pharmacia Corporation. ``With its ability to selectively block aldosterone, eplerenone either alone or in combination with other agents, holds the potential to contribute significantly to therapy for cardiovascular disease.''
Hypertension is the major risk factor affecting approximately 50,000,000 adult Americans. In 1999, it was listed as the primary or contributing cause of death in about 227,000 people. While there are many therapies currently available, two-thirds of the people living with hypertension do not have their blood pressure controlled and many require the use of multiple therapies.
Eplerenone Clinical Trials
As part of an ongoing Phase III program, eplerenone is also being evaluated in the filing Eplerenone Post-AMI Heart failure Efficacy and SUrvival Study (EPHESUS), as an investigational treatment for heart failure. EPHESUS has enrolled more than 6,600 patients at 650 centers in 37 countries. The trial is designed to examine whether the use of a selective aldosterone blocker will have a beneficial effect on survival and morbidity in patients who have suffered a heart attack and also have early complications of heart failure as identified by left ventricular dysfunction(1). The company anticipates filing an NDA for treatment of heart failure in the first half of 2003.
``If the premise for EPHESUS holds out, this trial may pave the way toward routine addition of eplerenone to treatment of heart failure,'' said Michael Tansey, MD, Chief Medical Officer and Senior Vice President, R&D Medical Development, Pharmacia Corporation. |
