FDA APPROVES NATRECOR (NESIRITIDE) FOR DYSPNEA IN CONGESTIVE HEART FAILURE PATIENTS

Entorno Médico, August 14th

Scios Inc. announced on August 13th that the company has received final approval from the U.S. Food and Drug Administration (FDA) to market Natrecor® (nesiritide) for the intravenous treatment of patients with acutely decompensated congestive heart failure (ADCHF) who have shortness of breath (dyspnea) at rest or with minimal activity. In this population, the use of Natrecor reduced pulmonary capillary wedge pressure, an important measure of heart function, and improved breathing. Natrecor is the first product to receive FDA approval for ADCHF showing an improvement in breathing in these patients.

Scios also announced that it has already established the marketing, sales and manufacturing capability necessary to launch Natrecor in U.S. hospitals by the end of August, where it will become the first new drug to treat this patient population in 14 years.

Natrecor is the first of a new drug class, called human B-type natriuretic peptides (hBNP), to be made available as a therapeutic for human disease in the United States. Natrecor is a recombinant form of hBNP, a natural protein found in the human body.

"The extensive data collected and reported on nearly 1,000 patients treated with Natrecor to date suggest an important role for this drug. ADCHF is a large and growing medical problem for which we have had no new drugs in over a decade," said James B. Young, M.D., Head of the Section of Heart Failure and Cardiac Transplant Medicine, and Medical Director of the Kaufman Center for Heart Failure, Cleveland Clinic Foundation. "Natrecor helps improve breathing and decreases pulmonary capillary wedge pressure, the two most important things we can do for these patients."

Natrecor may cause hypotension. In the pivotal trial, the incidence of symptomatic hypotension in the first 24 hours was similar for Natrecor (4 percent, n=273) and intravenous nitroglycerin (5 percent, n=216). When symptomatic hypotension occurred, however, the duration was longer with Natrecor (mean duration was 2.2 hours) than with nitroglycerin (mean duration was 0.7 hours).

Asymptomatic hypotension was reported in both Natrecor and nitroglycerin treated patients (8 percent versus 8 percent). Natrecor should be administered only in a setting where blood pressure can be monitored closely, and the dose of Natrecor should be reduced or the drug discontinued in patients who develop symptomatic hypotension.

Another reported side effect of Natrecor was headache (Natrecor [8 percent], nitroglycerin [20 percent]). Natrecor may affect renal function in susceptible individuals. At the recommended dose, the incidence of elevations in creatinine to >0.5 mg/dL above baseline through day 30 was 28 percent and 21 percent in the Natrecor and nitroglycerin groups, respectively. Natrecor should be initiated at the recommended dose. At doses higher than the recommended dose, Natrecor is associated with a higher risk of hypotension and increases in creatinine. Natrecor should not be used for patients with cardiogenic shock or in patients with a systolic blood pressure <90 mm Hg. Administration of Natrecor should be avoided in patients suspected of having, or known to have, low cardiac filling pressures.

During an episode of ADCHF, the heart's inability to adequately circulate blood throughout the body worsens beyond its already compromised state, causing symptoms to become so pronounced that hospital treatment is required to stabilize the patient's condition. A sudden increase in dietary sodium (salt), failure to take chronic oral medications, or the development of a new heart event can precipitate ADCHF. Virtually all CHF patients will have at least one acute episode, where the symptoms are so severe that often only intravenous (IV) medications administered in the hospital can improve patients' health.

About five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. There are approximately one million hospitalizations each year in the United States due to acute CHF, which cost the healthcare system $15 billion annually. Another two million Americans are hospitalized each year with acute CHF as the secondary diagnosis. In the U.S., CHF accounts for the largest cause of hospitalizations for patients over age 65. The impact of Natrecor on these costs is not known yet, but it will be certainly positive.
Source: Scios Inc. August, 14, 2001