(SCIO) said Monday that the Food and Drug Administration has granted final approval to Natrecor, a new drug to treat patients suffering from congestive heart failure.
Natrecor is Scios' first approved drug and the first new treatment for congestive heart failure approved in 14 years. The company said the drug will find its way into hospitals by the end of August.
Scios shares were up 5 cents to $20.40 in midday trading Monday.
Company executives are forecasting Natrecor sales of $10 million to $12 million this year. Various Wall Street analysts have said Natrecor peak sales could reach as much as $300 million per year.Natrecor is given to patients suffering from acute flare-ups of congestive heart failure, a condition afflicting 5 million Americans. About 1 million of these patients require hospitalizations that cost the health care system $23 billion annually. Drugs such as Natrecor could help patients suffering from life-threatening heart failure, and also reduce the cost of treatment. Right now, Natrecor stands alone because a rival drug from Genentech (DNA) suffered a big setback in late-stage testing in April. Natrecor actually suffered the same fate. The FDA rejected the drug in 1999, forcing Scios to conduct more tests. In May, an FDA advisory panel gave the drug the thumbs up, paving the way for Monday's final approval by the full FDA.