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Vertex forwards hepatitis C treatment for FDA approval

Tue, 11/23/2010 - 9:36am
Mass High Tech: The Journal of New England Technology

Vertex Pharmaceuticals Inc. said it has finished submitting its hepatitis C drug candidate to the U.S. Food and Drug Administration for approval. The submission is widely seen as a watershed moment for the company because the drug, if approved, is expected to be a blockbuster. If so, Vertex, after more than 20 years, would join the elite ranks of profitable biotechnology companies.

The Cambridge-based company’s FDA application is based on extensive data from three Phase 3 clinical trials testing both patients that were new to treatment and those who had previously received available treatments but had not attained a viral cure. To date, more than 2,500 people with genotype 1 hepatitis C have received the potential drug.

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