dm+d

36888211000001109

New Medicines

Delstrigo HIV infection, in adolescents aged ≥12 years

Information

Delstrigo
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 new indication for Delstrigo 100mg/300mg/245mg film-coated tablets to treat children aged 12 years and older (previously licensed only for use in adults). The new indication is treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil [5].
Mar 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 adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil” [2].

Category

Fixed-dose combination product containing a non-nucleoside reverse transcriptase inhibitor doravirine, plus lamivudine (nucleoside reverse transcriptase inhibitor) and tenofovir disoproxil fumarate (nucleotide 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 [1].
HIV infection, in adolescents aged ≥12 years
Oral

Evidence based evaluations