A Mountain View biotech firm cleared a key regulatory hurdle yesterday, but has one more test to pass before it wins final approval to sell a new drug to treat acute congestive heart failure.
12.
SAN FRANCISCO _ A Sunnyvale, Calif ., firm won U . S . Food and Drug Administration approval Monday for the first new treatment for acute congestive heart failure in more than a decade.
13.
In August, the U . S . Food and Drug Administration approved Natrecor, a genetically engineered version of a natural human protein known as B-type natriuretic peptide, for use in acute congestive heart failure.
14.
In the large-scale trial of patients with acute congestive heart failure, the drug, called NATRECOR, caused a statistically significant improvement in patients'symptoms as well as in two primary measures of the heart's overall functioning.
15.
If given final approval by the FDA, the drug, called Natrecor, would be the first new treatment for acute congestive heart failure in over a decade, according to Scios, which is based in Sunnyvale, Calif.
16.
Every year, acute congestive heart failure strikes an estimated 1 million people out of the nearly 4 million who suffer from chronic ongoing heart failure and is a leading cause of hospitalization in the U . S ., Casey said.
