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With Positive Boceprevir Data In Hand, Merck Prepares NDA Submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The race to bring the first oral protease inhibitor to market for the treatment of hepatitis C shows no signs of abating. Merck announced positive data from two Phase III trials evaluating boceprevir Aug. 4, along with plans to initiate a rolling NDA submission and complete the filing by the end of the year. That puts boceprevir on about the same regulatory trajectory as Vertex/Johnson & Johnson's telaprevir, which Vertex has said it will file in the second half of the year

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