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FDA replaces rather than rescinds Merck's breakthrough status

This article was originally published in Scrip

Executive Summary

The FDA reversed course on its intention to rescind the breakthrough therapy status it had awarded in October 2013 to Merck for its investigational combination hepatitis C virus (HCV) drug grazoprevir/elbasvir (MK-5172/MK-8742), and now the company holds not one, but two of the coveted designations for the experimental medicine.

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