FDA Approves AbbVie's Mavyret for All Genotypes of Hepatitis C in Pediatric Patients
30 April 2019 - 8:57PM
Dow Jones News
By Michael Dabaie
The U.S. Food and Drug Administration said Tuesday it approved
AbbVie Inc.'s (ABBV) Mavyret to treat all genotypes of hepatitis C
virus in children ages 12 to 17.
The FDA previously approved Mavyret to treat HCV in adults in
2017.
With the latest approval, dosing information is provided for
Mavyret for the treatment of adult or pediatric patients 12 years
and older, or weighing at least 99 pounds, who are infected with
any of six identified HCV genotypes either without cirrhosis or
with compensated cirrhosis.
The FDA said the safety and efficacy of Mavyret in pediatric
patients was evaluated during clinical trials of 47 patients with
genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild
cirrhosis.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
April 30, 2019 14:42 ET (18:42 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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