dm+d

36887911000001101

New Medicines

Pifeltro HIV infection, in adolescents aged ≥12 years

Information

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

Development and Regulatory status

Launched
Launched
Launched
May 2022
May 22MHRA approves a licence change for Pifeltro 100 mg film-coated tablets to include use in children aged 12 years and older (previously licensed only for use in adults). The new indication is use in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV-1 without past or present evidence of resistance to the NNRTI class [5].
Apr 22Licence change approved in the EU [4].
Feb 22Approved in the US for treatment of HIV-1 infection in children aged 12 years and older weighing at least 35kg [3].
Feb 22EU positive opinion granted recommending a licence change to include use in children aged 12 years and older (previously licensed only for use in adults). The proposed new indication is “for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV‑1 without past or present evidence of resistance to the NNRTI class" [1].

Category

A non-nucleoside reverse transcriptase inhibitor.
There are nearly 106,000 people living with HIV in the UK. In 2019, ~4,000 people were newly diagnosed with HIV in the UK [2].
HIV infection, in adolescents aged ≥12 years
Oral

Evidence based evaluations