Boceprevir Officially Fast-Tracked
January 12, 2011
Merck’s new oral hepatitis C drug boceprevir will receive fast track reviews from both the FDA and the EMA after the regulators decided it marked a major advance in treatment.
The FDA has granted Merck’s investigational protease inhibitor priority review status, a move that could see the drug on the market within six months.
The US regulator’s European counterpart the EMA has also accepted the marketing Merck’s boceprevir application for accelerated assessment.
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