MAVYRET

批准信原文要点

These Prior Approval supplemental new drug applications provide for revisions to the labeling to include the indication for the treatment of acute hepatitis C virus (HCV) infection in adults and pediatric patients ages 3 to less than 18 years of age.

批准信原文要点

This Prior Approval sNDA provides for a new blister packaging presentation for Mavyret (glecaprevir/pibrentasvir) tablets.

批准信原文要点

These Prior Approval sNDAs update the DRUG INTERACTIONS section of the US Prescribing information with drug-drug interaction data on the coadministation of ethinyl estradiol-containing products with glecaprevir and pibrentasvir.

批准信原文要点

These “Changes Being Effected” sNDAs provide for the following changes to the USPI: • Change the carton size from 60 packets to 28 packets for Mavyret (glecaprevir/pibrentasvir) oral pellets • Addition of a bottle configuration (within a carton) for Mavyret (glecaprevir/pibrentasvir) Tablets • Corresponding changes to the Instructions for Use

批准信原文要点

These applications provide for the following: • Safety and efficacy data from Study M16-123 Part 2 to support the use of Mavyret (glecaprevir and pibrentasvir) oral pellets for the treatment of pediatric patients 3 to less than 12 years of age weighing less than 45 kg with chr…

批准信原文要点

This Prior Approval supplemental new drug application provides for the following changes to the MAVYRET® US Prescribing Information (USPI): • Addition of data to CLINICAL PHARMACOLOGY, subsection 12.4 and CLINICAL TRIALS, subsection 14.4 from VOYAGE-1 and VOYAGE-2 clinical trials conducted in subjects with chronic hepatitis C virus genotype 3b infection. • Addition of information in people who inject drugs (PWID) and those on medication-assisted treatment (MAT) for opioid use disorder to 6.1, Clinical Trials Experience, subsection 6.1, USE IN SPECIFIC POPULATIONS, subsection 8.8, and CLINICAL TRIALS, subsection 14.9.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following changes to the MAVYRET™ US Prescribing Information (USPI): • To provide safety and efficacy data to support an 8-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naïve subjects with compensated cirrhosis based on the results from the EXPEDITION-8 Study.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following changes to the MAVYRET™ US Prescribing Information (USPI): • Addition of safety and efficacy data for subjects with genotype (GT) 5 and 6 Hepatitis C Virus (HCV) infection from the ENDURANCE-5,6 study • Contraindicate the use of MAVYRET™ in patients with moderate hepatic impairment (Child-Pugh B) or those with any history of prior hepatic decompensation

批准信原文要点

This Prior Approval supplemental new drug application provides for changes to the MAVYRET™ US Package Insert (USPI) to expand the indication to adolescents 12 years and older or weighing at least 45 kilograms (kg) supported by safety and efficacy data from Part 1 of the Phase 2/3 open label Study M16-123.

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to the MAVYRET US Prescribing Information (USPI) to include safety and efficacy data from the HCV/HIV-1 coinfection study (M14-730) and from the liver and renal transplant study (M13-596).

批准信原文要点

This Prior Approval supplemental new drug application provides an update to the DRUG INTERACTIONS section of the Prescribing Information with information pertaining to fluctuations in International Normalized Ratio (INR) values in patients receiving warfarin concomitantly with MAVYRET.