FDA OKs Scios' CHF drug, first in a decade

13 August 2001

The US Food and Drug Administration has approved the first new drug inover a decade for the treatment of congestive heart failure. Scios has gained clearance for its recombinant human B-type natriuretic peptide Natrecor (nesiritide) as an intravenous treatment for patients suffering from acutely decompensated CHF who have shortness of breath at rest or with minimal activity.

The recent unanimous vote by an FDA advisory panel in favor of approval (Marketletter June 4) followed a series of setbacks for the drug, including the agency's rejection two years ago of Scios' New Drug Application, despite a narrow vote by the panel in favor of approval, due to inconclusive safety and efficacy data. The firm addressed the issues raised by the FDA (such as the observation that the drug caused hypotension in 8%-14% of patients, depending on the dose, as well as affecting renal function in susceptible individuals) in the VMAC (Vasodilation in the Management of Congestive heart failure) trial which compared Natrecor to nitroglycerin (standard CHF treatment) and placebo.

Results demonstrated that an injection containing a lower dose of Natrecor performed better than nitroglycerin or placebo on the primary endpoints of pulmonary capillary wedge pressure and dyspnea, reducing the incidence of hypotension to 4%, and this effect was sustained for up to 48 hours with no loss of efficacy (Marketletter November 20, 2000).

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