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FDA ADVISORY COMMITTEE TO REVIEW NATRECOR NEW DRUG APPLICATION
SCIOS ANNOUNCES FDA CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE TO REVIEW NATRECOR NEW DRUG APPLICATION
SUNNYVALE, CA, April 10, 2001 - Scios Inc. (Nasdaq: SCIO) announced today that the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee will review the company's New Drug Application (NDA) amendment for Natrecor (nesitritide) for the treatment of acute congestive heart failure (CHF) on Friday, May 25, 2001.
Scios submitted an amendment to its existing NDA for Natrecor at the beginning of this year, based largely on the findings of the 498-patient VMAC (Vasodilation in the Management of Acute Congestive heart failure) trial. If approved, Natrecor would be the first new treatment for acute CHF in more than a decade.
"We are pleased to have the opportunity to present all of the Natrecor data, particularly the VMAC data, to the FDA Advisory Committee," said Darlene P. Horton, M.D., Scios' Vice President of Medical Affairs. "We have been working closely with the Agency and believe we can present a compelling case regarding the approvability of this drug."
In addition to Dr. Horton from Scios, James B. Young, M.D., Chair, VMAC Steering Committee and Head, Section of Heart Failure and Cardiac Transplant Medicine and Medical Director of the Kaufman Center for Heart Failure at the Cleveland Clinic Foundation and William Abraham, M.D., Chief, Division of Cardiovascular Medicine and Director, Section of Heart Failure and Cardiac Transplantation, University of Kentucky College of Medicine, will present Natrecor data.
"The Advisory Committee review of the data supporting the application for approval of Natrecor is an important step for Natrecor and an important event for other applications to follow for this indication," commented Richard B. Brewer, Scios' Chief Executive Officer. "As we have indicated previously, we have been expecting and preparing for Advisory Committee review."
Natrecor is a recombinant form of B-type natriuretic peptide (BNP), a naturally occurring hormone in the body that aids healthy functioning of the heart. It causes arteries and veins to dilate, alleviating symptoms by improving blood movement around the heart without a change in heart rate. Natrecor is administered intravenously, primarily in a standard fixed dose regimen that not require titration (i.e., dose adjustments). Roughly five million Americans suffer from heart failure, and there are approximately one million hospitalizations each year in the United States for acute heart failure.
Immediately following the Advisory Committee meeting, Scios will host a conference call and webcast to discuss the results of the meeting. The webcast and conference call will begin at 6:00 pm (ET) on Friday, May 25th. The webcast will be available on Scios' website, www.sciosinc.com. The conference call dial-in will be (800) 314-7867. A replay of both the conference call and webcast will be available through June 1, 2001. The replay dial-in number will be (888) 203-1112, confirmation code 593777.
Scios Inc. Scios is a biopharmaceutical company developing novel treatments for heart failure and rheumatoid arthritis. The company's disease-based technology platform integrates expertise in protein biology with combinatorial and medicinal chemistry to identify novel targets and rationally design large and small-molecule compounds to treat cardiovascular and inflammatory diseases, two of the world's leading unmet medical needs. Additional information on Scios is available at its web site located at www.sciosinc.com and in the company's various filings with the Securities and Exchange Commission.
The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. These include uncertainties associated with anticipating the response of the FDA and the Advisory Committee to the results of the VMAC trial, the timing of regulatory approval of Natrecor, and acceptance by the medical community of Natrecor as a new therapy for acute decompensated CHF, as well as other risks detailed from time to time in the reports filed by Scios with the SEC, including the company's annual report on form 10-K for the year ended December 31, 2000.
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