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33435211000001107

New Medicines

Zepatier Hepatitis C infection in children aged 12 years and older

Information

Zepatier
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Launched
Launched
Launched
December 2021
Feb 22Approved in the EU [5].
Dec 21FDA approves use of Zepatier in children aged 12 years and older weighing at least 30kg [3].
Dec 21Licence extension approved by MHRA for use in children aged 12 years and older. The new indication is treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30kg [1].
Sep 21EU CHMP recommends an extension to the existing indication as follows: Zepatier is indicated for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients 12 years of age and older who weigh at least 30kg [2].

Category

All-oral combination regimen: MK-5172 is a NS3/4A protease inhibitor, and MK-8742 a NS5A replication complex inhibitor. Taken once-daily.
Prevalence of HCV infection in children and adolescents has been reported to vary from 0.05% to 0.36% in the US and Europe [4].
Hepatitis C infection in children aged 12 years and older
Oral

Evidence based evaluations