Merck blood thinner gets 'yes' vote from FDA panel
Thursday, January 16, 2014
WASHINGTON (AP) — A panel of federal experts has recommended approval for an experimental blood thinner from Merck despite serious side effects including internal bleeding.
The Food and Drug Administration's panel of cardiology experts voted 10-1 Wednesday in favor of approving the pill vorapaxar to help prevent blood clots in patients with a history of heart attacks.
"I think this drug addresses an important unmet need and can make a real difference for patients," said Dr. Philip Sager of Stanford University, who chaired the panel.
Many industry analysts had previously written the drug off due to safety concerns that led Merck to shut down one large study and halt enrollment of another. Both studies found that the drug significantly increased the risk of internal bleeding, including dangerous bleeding inside the skull. But when the drug was limited to patients who had no history of strokes it helped reduce heart attacks, strokes and death.
Merck has asked the FDA to approve the drug for this relatively narrow group of patients who have had a recent heart attack but have not had a stroke or internal bleeding. Merck had originally sought a broader market.
The Whitehouse Station, N.J., company wants to market the drug under the brand name Zontivity.
Merck & Co. Inc. told panelists Wednesday that 5 to 10 percent of patients who go the hospital with a heart attack will have another heart-related medical emergency within the next year. If approved, the drug would be used as an add-on therapy with other common blood thinners, such as aspirin.
Vorapaxar is part of a new generation of anti-clotting drugs meant to prevent deadly heart attacks and blood clots in the millions of people at risk for them. Drugmakers have generally touted these therapies as more effective and safer than Coumadin, known chemically as warfarin. That's been the standard treatment for decades despite the need for frequent blood tests to ensure it is being dosed properly.
Merck's drug was once thought to be a potential blockbuster medication before its bleeding risks came to light in 2011. Merck conceded the drug's diminished prospects when it took a $1.7 billion charge to write down the value assigned to vorapaxar. Merck acquired the compound through its November 2009 purchase of Schering-Plough Corp.
If the drug is ultimately approved it will enter a crowded field of new blood thinning drugs, including Boehringer Ingelheim's Pradaxa,; Johnson & Johnson and Bayer Healthcare's Xarelto and Pfizer Inc. and Bristol-Myers Squibb Co.'s Eliquis, which was approved in late 2012.
Those drugs are already approved for a slew of uses in preventing strokes and blood clots in patients with a variety of health conditions.
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