NEW YORK (AP) — Shares of Merck rose Monday on the suggestion that its anticlotting drug vorapaxar might be approved for sale despite concerns about an increased risk of bleeding.
THE SPARK: A panel of Food and Drug Administration advisers is scheduled to review vorapaxar on Wednesday, and documents related to the meeting were posted on the FDA's website Monday. A review by FDA scientists recommends that the drug be approved based on "robustly positive" results from a key clinical trial.
On Wednesday the FDA will ask its panel of outside cardiology experts to assess the drug's safety and effectiveness. The FDA is not required to follow the group's recommendations, though it usually does.
THE BIG PICTURE: Vorapaxar is designed to prevent heart attacks and strokes. It is part of a new generation of anti-clotting drugs meant to prevent the death and disability that strokes and heart attacks cause in the millions of people at risk for them. However safety concerns have clouded its chances of approval: while the drug reduced the risk of heart attack, stroke, and death from heart disease or emergency surgery in some studies, it was linked to an increased risk of bleeding in two different clinical trials.
In one study, patients on the drug were more likely to suffer major bleeding, including bleeding inside the skull. That can cause a stroke, brain damage or death. Merck even took a $1.7 billion charge to write down the value of the drug.
Merck is asking the FDA to approve the drug for patients who don't have a history of stroke or transient ischemic attack. It wants to market it under the name Zontivity.
Merck also said Monday that it has started filing for approval of its drug MK-3475 as a treatment for advanced melanoma. It expects to complete the filing in the first half of 2014. Merck wants the FDA to approve MK-3475, or lambrolizumab, as a treatment for advanced melanoma. MRK-3475 is designed to use the immune system to fight cancer, and Merck said it is running 10 clinical trials of the drug.
The Whitehouse Station, N.J., company also said it will sell its Sirna Therapeutics unit to Alnylam Pharmaceuticals Inc. for $175 million in cash and stock.
SHARE ACTION: Shares of Merck & Co. gained $3.31, or 6.6 percent, to $53.19 in afternoon trading. Earlier they reached a five-year high of $53.44.