dm+d

30250511000001101

New Medicines

EvotazHIV infection in adolescents

Information

Evotaz
Licence extension / variation
Gilead Sciences
Bristol-Myers Squibb

Development and Regulatory status

Launched
Recommended for approval (Positive opinion)
Launched
July 2021
Jul 21Licence extension for use in adolescents approved by the MHRA. The new indication is use in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir [5].
May 21Has been licensed for use in children weighing at least 35kg in the US since Jul 2020 [3].
May 21EU positive opinion for a licence change to recommend use in adolescents (previously only licensed for use in adults. the proposed indication is use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir [2].

Category

Fixed-dose combination protease inhibitor and an investigational pharmacokinetic enhancer
In 2016, 41 children were newly diagnosed with HIV – down from 131 in 2005. Of these, 36 were born abroad and arrived in the UK at an older age [1].
HIV infection in adolescents
Oral