FDAnews
www.fdanews.com/articles/91358-lipitor-gains-five-new-heart-disease-indications

LIPITOR GAINS FIVE NEW HEART DISEASE INDICATIONS

March 14, 2007

The FDA has cleared Pfizer's Lipitor for five new heart disease indications, including the reduction of the risk of hospitalization due to heart failure.

The new indications include reduction in the risk "of nonfatal heart attacks, fatal and non-fatal strokes, certain types of heart surgery, hospitalization for heart failure and chest pain in patients with heart disease," Pfizer said last week.

The company noted that Lipitor (atorvastatin) is the first cholesterol medication to be approved for the reduction of the risk of hospitalization for heart failure.

"This new approval expands the use of Lipitor to patients at high risk for cardiovascular events because of established heart disease such as prior heart attack, prior heart surgery or chest pain with evidence of clogged arteries," Pfizer said.

Previously, the statin's cardiovascular disease indications were limited to patients without heart disease, the firm said. The approvals expand Lipitor's extensive list of indications, which now comprises 17 approved uses. The firm said it does not expect any change from its previous prediction of "modest growth" for Lipitor sales this year.

The new indications will likely complement Pfizer's advertising campaign, launched in October 2006, which highlights atorvastatin's benefits in the prevention of heart attack and stroke. The campaign was initiated to counteract increased competition resulting from generic approvals of Bristol-Myers Squibb's Pravachol (pravastatin) and Merck's Zocor (simvastatin).