New Blood Thinner Gets Preliminary FDA OK

Monday, 13 Jan 2014 12:30 PM

 

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Merck & Co Inc's experimental blood clot-preventing drug vorapaxar should be approved, based on "robustly positive" clinical trial results, according to a preliminary review of the data by the U.S. Food and Drug Administration.
 
The review, posted on the FDA's website on Monday, comes two days ahead of a meeting of outside medical experts, who are expected to recommend whether it should be approved. The FDA usually follows the advice of its advisory panels.

The drug, which would be sold under the brand name Zontivity, is designed to prevent heart-related deaths, cardiac arrests and strokes in patients who have had a recent heart attack but not a stroke.
 
Results from a trial known as TRA 2P "are sufficient to establish the effectiveness of vorapaxar for its proposed indication," the review found.
 
The main safety concern with the drug is bleeding, the review found, though it noted that the rate of fatal bleeding was low in the population for whom the drug is being proposed.
 
The FDA did not recommend that the company establish a risk management program, nor did it recommend that the company conduct additional trials following approval.

© 2014 Thomson/Reuters. All rights reserved.

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