VOSEVI

批准信原文要点

This Prior Approval supplemental new drug application provides for the following: • The use of Vosevi for the treatment of chronic hepatitis C virus infection in patients with severe renal impairment including patients with end stage renal disease on dialysis. • The addition of carbamazepine and rifabutin information to CLINICAL PHARMACOLOGY, Table 6. • The addition of data from Study TX-281-2030, a rat carcinogenicity study, to support labeling changes in NONCLINICAL TOXICOLOGY.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following changes to the US Prescribing Information (USPI): • Addition of new subsection 5.2 under the WARNINGS AND PRECAUTIONS regarding the risk of hepatic decompensation/failure in patients treated with HCV NS3/4A protease inhibitor containing direct acting antiviral (DAA) regimens, including treatment with VOSEVI • Update ADVERSE REACTIONS, Postmarketing Experience subsection 6.2 with hepatic decompensation/failure with NS3/4A protease inhibitor-containing regimens • Update the DRUG INTERACTIONS Section, 7.3 subsection with information regarding the risk of dysglycemia in patients with diabetes • Update the USE IN SPECIFIC POPULATIONS, subsection 8.7 with the information regarding postmarketing cases of hepatic decompensation/failure

批准信原文要点

This Prior Approval supplemental new drug application provides for the followings revisions: • Update the DRUG INTERACTIONS section with information pertaining to fluctuations in International Normalized Ratio (INR) values in patients receiving warfarin concomitantly with VOSEVI. • Update the DRUG INTERACTIONS and CLINICAL PHARMACOLOGY sections regarding the potential drug interaction between VOSEVI and atorvastatin.