Scios Asks Leading Cardiologist to Convene External Panel of Experts to Assess Important Data and Clinical Development Program for NATRECOR(R)
FREMONT, Calif., April 12 /PRNewswire/ — Scios Inc. announced today that a panel of external cardiology and heart failure experts will be convened to review and assess important data associated with its acute heart failure treatment NATRECOR(R) (nesiritide). The panel will also provide guidance and counsel on the ongoing and planned clinical development program for the product. Eugene Braunwald, M.D., Distinguished Hersey Professor of Medicine, Harvard Medical School, and Chairman TIMI Study Group at Brigham and Women’s Hospital in Boston, will chair the panel and identify all panel members.
“Nesiritide has proven to be a useful drug with intriguing properties that needs to be explored further,” said Dr. Braunwald. “A recent publication has raised questions about its safety and the potential need for additional data to ensure the appropriate use of NATRECOR(R). The panel I will convene will examine all of the existing data and the planned clinical development program to assess the questions raised and to make recommendations to the manufacturer.”
“With the best interests of our patients in mind, we are committed to answering the most important questions that heart failure experts may have about NATRECOR(R),” said Darlene Horton, M.D., Senior Vice President of Clinical Research and Medical Affairs at Scios. “We are confident in the safety profile of NATRECOR(R) and the benefits it offers to patients and we look forward to the thoughtful, objective insights that Dr. Braunwald and the panel will provide.”
Thirteen company-sponsored clinical trials involving NATRECOR(R) have been completed to date and data from all thirteen studies have been shared with the FDA. The company is in the process of posting the details of all thirteen studies to the NATRECOR(R) Web site. A number of prospective clinical trials are also underway and additional large-scale studies are planned. The details of these studies will be announced in the coming months.
About NATRECOR(R)
NATRECOR(R) (nesiritide) is indicated for the intravenous (IV) treatment of patients with acutely decompensated congestive heart failure (CHF) who have dyspnea at rest or with minimal activity. In this population, the use of NATRECOR(R) reduced pulmonary capillary wedge pressure (PCWP) and improved dyspnea.
Important Safety Information
NATRECOR(R) (nesiritide) may cause hypotension. If hypotension occurs during administration of NATRECOR(R), the dose should be reduced or discontinued, and blood pressure should be monitored closely. At the recommended dose of NATRECOR(R), the incidence of symptomatic hypotension (4%) was similar to that of IV nitroglycerin (5%). Asymptomatic hypotension occurred in 8% of patients treated with either drug. The mean duration of symptomatic hypotension was longer with NATRECOR(R) than IV nitroglycerin (2.2 versus 0.7 hours, respectively).
NATRECOR(R) may affect renal function in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with NATRECOR(R) may be associated with azotemia. Other adverse events reported at a rate of at least 5% during the first 24 hours of infusion with either NATRECOR(R) plus standard care or IV nitroglycerin plus standard care therapy, included, respectively: ventricular tachycardia (3%, 5%), nonsustained ventricular tachycardia (3%, 5%), headache (8%, 20%), abdominal pain (1%, 5%), and nausea (4%, 6%).
Higher doses of NATRECOR(R) increased the risk of hypotension and elevated creatinine. NATRECOR(R) should not be used in patients with systolic blood pressure <90 mm Hg, or as primary therapy in patients with cardiogenic shock.
NATRECOR(R) is not recommended for patients for whom vasodilating agents are not appropriate and should be avoided in patients with low cardiac filling pressures.
Please see accompanying full Prescribing Information for NATRECOR(R).
About Scios Inc.
Scios Inc., a Johnson & Johnson company, is a biopharmaceutical company headquartered in Fremont, California. Scios is developing novel treatments for cardiovascular disease, inflammatory disease and cancer. The Company’s disease-based technology platform integrates expertise in protein biology with computational and medicinal chemistry to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs. For more information, visit http://www.sciosinc.com/.
Scios Inc.
CONTACT: Chris B. Ernst of Scios Inc., +1-415-710-9445; or Mark T. Wolfeof Johnson & Johnson, +1-908-672-4988
Web site: http://www.sciosinc.com/