dm+d

34733311000001105

New Medicines

Maviret (EU); Mavyret (US)Chronic hepatitis C infection, with genotypes 1-6 in children and adolescents

Information

Maviret (EU); Mavyret (US)
Licence extension / variation and new formulation
AbbVie
AbbVie

Development and Regulatory status

Launched
Launched
Launched
March 2019
Sep 21MHRA extend UK licence to include use in children aged ≥3 years; the full indication is for the treatment of chronic HCV infection in adults and children 3 years and older. A new granule formulation has been approved for use in children 3-11 years of age and weighing 12-44 kg [7].
Apr 21EU positive opinion for a licence change to include use in children from the age of 3 (previously from the age of 12 years). The proposed indication is treatment of chronic hepatitis C virus (HCV) infection in adults and in children aged 3 years and older [6].
May 19Approved in US [5].
Mar 19Licence change approved in EU [4].
Jan 19Recommended for EU approval by CHMP - the extension adds "in adolescents aged 12 to <18 years" to the current indication of treatment of chronic hepatitis C virus (HCV) infection in adults [3].

Category

Fixed dose combination of glecaprevir (NS3 protease inhibitor, with in vitro activity against a broad range of HCV genotypes, including variants with strong resistance to first-generation protease inhibitors) & pibrentasvir (NS5A inhibitor).
Estimates from the Health Protection Agency in 2011 show that HCV was newly diagnosed in 26 people aged 1 year or younger and 21 people aged 1–14 years in England in 2010 [2].
Chronic hepatitis C infection, with genotypes 1-6 in children and adolescents
Oral

Trial or other data

Apr 18PIII DORA trial is still recruiting [1].
Mar 17PIII DORA trial to evaluate the pharmacokinetics, safety and efficacy of glecaprevir/pibrentasvir in 100 children aged 3 years to 17 years with genotypes 1-6 chronic hepatitis C infection starts (M16-123; NCT03067129). 100 patients will be enrolled in several countries including the US & EU (plus UK). Collection of primary outcome data is due to complete Sep 19 [1].

Evidence based evaluations