Genetic drug on tap for acute CHF
FDA committee OKs hormone-derived treatment
In January, the Food and Drug Adminis tration’s cardiovascular and renal drugs advisory committee recommended the first genetically engineered drug therapy for chronic heart failure (CHF) treatment. Scios Inc. in Mountain View, CA, is seeking an indication for Natrecor (nesiritide) as a short-term treatment for acute episodes of CHF.
The drug is the genetically engineered form of the cardiac hormone b-type natriuretic peptide (hBNP), which the body secretes in response to its failing heart. The company filed its new drug application in the spring of 1998 after Phase III trials. Trial outcomes included decreases in pulmonary capillary wedge pressure, a distinct blood pressure marker of the heart that researchers know can force fluid into the lungs if not controlled; and increases in the amount of blood pumped into circulation for the internal organs, known as the cardiac index.
Bayer AG has entered into an agreement to market the drug upon final approval. (For more on nesiritide, consult Scios’ Web site at www. sciosinc.com.)