FDA Staffers: Vertex Hep C Drug More Effective Than Current Therapies

One step closer to market?

The Boston Globe reports that Cambridge-based Vertex Pharmaceuticals is one step closer to getting its first drug on the market:

A proposed drug developed by Vertex Pharmaceuticals Inc. cures more patients with the hepatitis C virus in less time than existing therapies, according to a briefing document filed today by Food and Drug Administration staffers who reviewed the new drug application.

The drug, called telaprevir, would be used in combination with two current therapies. Together, the drug “cocktail” proved more effective in late-stage clinical trials than the older drugs by themselves, the briefing paper said. The document was prepared in advance of a day-long hearing Thursday by an FDA advisory committee that will recommend whether the agency should approve the new drug.

Tomorrow the same FDA advisory committee will consider a rival hepatitis C treatment, boceprevir, developed by Merck & Co. Both drugs act to inhibit the protease enzyme that enables the virus to reproduce, and both target a market projected by some securities analysts to exceed $2 billion annually this year and in 2012.

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