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| Vertex Pharmaceuticals Inc |
(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX - News) announced that NASDAQ today halted trading of the company's common stock. The United States Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee meets today in Silver Spring, MD to review the New Drug Application (NDA) for telaprevir.
The NDA for telaprevir was granted Priority Review by the FDA, and the FDA is expected to make a decision on the approval of telaprevir by May 23, 2011 under the Prescription Drug User Fee Act (PDUFA). The NDA includes data from three registration studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in combination with pegylated-interferon and ribavirin in people who were not treated previously and in the three major subgroups of people who were treated previously but who were not cured with currently available medicines - relapsers, partial responders and null responders.
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