FDA Advisors Give Nod to Heart Failure Drug
FDA Advisors Give Nod to Heart Failure Drug
May 25, 2001 (Bethesda, Md.) -- The first new treatment for congestive heart failure in more than a decade was recommended for approval by a panel of advisors to the FDA Friday.
The drug Natrecor, made by Scios, is a variation of natural hormones secreted by the heart to help it when it's struggling to pump blood.
Congestive heart failure, or CHF, is a condition in which the heart cannot effectively pump blood to the tissues of the body. There hasn't been a new drug for CHF in nearly 13 years, so a new medicine for this condition, the treatment of which costs American $38 billion annually, could have considerable significance. The recommendation now goes to the full FDA for action.
The 10-member panel voted unanimously for the drug, except one member wanted a special "black box" warning for the risk of severe low blood pressure. However, committee chairman Milton Packer, MD, of Columbia University tells WebMD he doesn't believe that will be necessary.
"We have a great deal of faith that physicians when appropriately informed will do the right thing," he says. Kidney function should also be monitored for those on the drug to prevent any long-term damage, he says.
The FDA had already turned thumbs down on Natrecor once. In April of 1999, the agency expressed concern that higher doses of the drug could result in a dangerous drop in blood pressure. The medication is designed to improve blood flow to the heart.
But the regulators also wanted other studies to show how the medicine performed compared to existing treatments. The key questions were would Natrecor improve the blood's circulation as measured by a so-called "wedge" blood pressure reading, and would the medicine help people breathe easier? The FDA also wanted to see that "sicker" CHF failure patients weren't excluded from the research.
Scios responded to the questions with a multicenter study involving almost 500 patients. Of those, about half had a procedure known as a catheterization in which a tube is inserted in the right side of the heart to measure the organ's output.
FDA Advisors Give Nod to Heart Failure Drug
May 25, 2001 (Bethesda, Md.) -- The first new treatment for congestive heart failure in more than a decade was recommended for approval by a panel of advisors to the FDA Friday.
The drug Natrecor, made by Scios, is a variation of natural hormones secreted by the heart to help it when it's struggling to pump blood.
Congestive heart failure, or CHF, is a condition in which the heart cannot effectively pump blood to the tissues of the body. There hasn't been a new drug for CHF in nearly 13 years, so a new medicine for this condition, the treatment of which costs American $38 billion annually, could have considerable significance. The recommendation now goes to the full FDA for action.
The 10-member panel voted unanimously for the drug, except one member wanted a special "black box" warning for the risk of severe low blood pressure. However, committee chairman Milton Packer, MD, of Columbia University tells WebMD he doesn't believe that will be necessary.
"We have a great deal of faith that physicians when appropriately informed will do the right thing," he says. Kidney function should also be monitored for those on the drug to prevent any long-term damage, he says.
The FDA had already turned thumbs down on Natrecor once. In April of 1999, the agency expressed concern that higher doses of the drug could result in a dangerous drop in blood pressure. The medication is designed to improve blood flow to the heart.
But the regulators also wanted other studies to show how the medicine performed compared to existing treatments. The key questions were would Natrecor improve the blood's circulation as measured by a so-called "wedge" blood pressure reading, and would the medicine help people breathe easier? The FDA also wanted to see that "sicker" CHF failure patients weren't excluded from the research.
Scios responded to the questions with a multicenter study involving almost 500 patients. Of those, about half had a procedure known as a catheterization in which a tube is inserted in the right side of the heart to measure the organ's output.
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