Issue 115 Item 12 New Statin and Aspirin Combo gets FDA Panel Support

It will be a combination package in 3 strengths of pravastatin and 2 strengths of aspirin. Advisors to the US Food and Drug Administration (FDA) on Thursday reversed an earlier panel decision and endorsed the co-packaging of Bristol-Myers Squibb Company’s Pravachol (pravastatin) with low-dose aspirin for the prevention of various cardiovascular events, including acute heart attacks.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted in support of permitting the New York City-based drugmaker to co-package and market three different doses of Pravachol with either 81mg or 325mg of aspirin.

The vote reversed an earlier recommendation by the same FDA advisory committee back in January, due in part to concerns that the co-packaged product would limit treatment flexibility and mask patients’ contaminate use of aspirin.

Bristol-Myers Squibb earned the committee’s backing for a revised application that was amended to include additional packages with either 20mg or 40mg of Pravachol.

"There is an issue and there is some risk here that someone will get aspirin that shouldn’t," added committee member Dr. Steven Nissen, vice chairman of the Department of Cardiology at the Cleveland Clinic Foundation in Ohio.

Others also argued that the expected improvement in patient compliance is at best speculation, although the benefits of co-packaging may appear self-evident.

The FDA often follows its committees’ recommendations, but the agency is not bound by their advice.