Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
04/30/2019
Trade Name:
Mavyret
Generic Name or Proper Name (*):
glecaprevir and pibrentasvir
Indications Studied:
Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Label Changes Summary:
*Expanded the indication to adolescents 12 years and older or weighing at least 45 kilograms (kg); previously approved in adults. *Safety, efficacy, and pharmacokinetics in HCV GT1, 2, 3, or 4 infected pediatric patients 12 years and older or weighing at least 45 kg is based on data from an open-label trial in 47 subjects without cirrhosis aged 12-18 years who were either treatment naïve (n=36) or treatment experienced (n=11) and received Mavyret for 8 or 16 weeks. *The safety and efficacy results observed in this trial were consistent with those observed in clinical studies of Mavyret in adults. *In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or HCV GT5 or 6 infection, the safety and efficacy of Mavyret are supported by the comparable glecaprevir and pibrentasvir exposures observed between adolescents and adults. *Safety and effectiveness in children less than 12 years of age have not been studied. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study.
Product Labeling:
[INVALID]
BPCA(B) and PREA(P):
B, P
Sponsor:
AbbVie
NNPS:
FALSE
Therapeutic Category:
Antiviral
-
-