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European committee endorses Victrelis for approval
WHITEHOUSE STATION, N.J. (AP) -- Drugmaker Merck & Co. said Friday that a European drug agency has endorsed its hepatitis C treatment Victrelis, also known as boceprevir -- a key step toward possible approval in the European Union.
The Whitehouse Station, N.J., company said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approving the drug. The European Commission, which approves medicines for the European Union, usually makes a decision on these recommendations in two or three months.
The European committee recommended approval of the drug for use in combination with standard treatments in untreated adults or people who have had previous therapy that failed.
The U.S. Food and Drug Administration approved Victrelis last week. The highly anticipated drug is a first-of-its-kind pill that has been shown to cure more patients in less time than the older drugs now used.
Boceprevir works by blocking the enzyme protease that helps hepatitis reproduce. It differs from older medications that boost the immune system. Analysts expect it to reach annual sales between $800 million and $1 billion.
Hepatitis C is the primary cause of liver transplants in the U.S. People can get the disease by sharing needles or having sex with an infected person.
Merck said Tuesday it's reached a deal with Roche Holding AG to promote Victrelis pills as part of a new triple combination therapy, with Roche's injected hepatitis C drug Pegasys and ribavirin pills.
Approval is expected soon for another new hepatitis C treatment, Incivek from Vertex Pharmaceuticals of Cambridge, Mass.
The Whitehouse Station, N.J., company said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approving the drug. The European Commission, which approves medicines for the European Union, usually makes a decision on these recommendations in two or three months.
The European committee recommended approval of the drug for use in combination with standard treatments in untreated adults or people who have had previous therapy that failed.
The U.S. Food and Drug Administration approved Victrelis last week. The highly anticipated drug is a first-of-its-kind pill that has been shown to cure more patients in less time than the older drugs now used.
Boceprevir works by blocking the enzyme protease that helps hepatitis reproduce. It differs from older medications that boost the immune system. Analysts expect it to reach annual sales between $800 million and $1 billion.
Hepatitis C is the primary cause of liver transplants in the U.S. People can get the disease by sharing needles or having sex with an infected person.
Merck said Tuesday it's reached a deal with Roche Holding AG to promote Victrelis pills as part of a new triple combination therapy, with Roche's injected hepatitis C drug Pegasys and ribavirin pills.
Approval is expected soon for another new hepatitis C treatment, Incivek from Vertex Pharmaceuticals of Cambridge, Mass.
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