Asunaprevir NDA Withdrawal Likely To Mean Daclatasvir Delay
This article was originally published in Pharmaceutical Approvals Monthly
Bristol pulls NDA for its second-generation protease inhibitor, which likely will alter the data needed for approval of its simultaneously filed NS5A inhibitor. Recent approval of daclatasvir in Europe may offer a glimpse at Bristol’s revised U.S. strategy in HCV.
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Merck and Bristol will run a Phase II trial testing daclatasvir, an NS5A replication complex inhibitor, in tandem with MK-5172, Merck’s potentially pan-genotypic protease inhibitor in a non-exclusive partnership in hepatitis C. It’s the second such deal Bristol has signed this month, following an April 5 agreement with Vertex.
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