Tag: ViiV Healthcare

FDA approves Cabenuva for some adolescents living with HIV
March 29, 2022 Off

FDA approves Cabenuva for some adolescents living with HIV

By Dino Mustafić

US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

ViiVHC kicked off rolling submission for investigational therapy for HIV prevention
May 4, 2021 Off

ViiVHC kicked off rolling submission for investigational therapy for HIV prevention

By Dino Mustafić

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced the initiation of a rolling submission of a new drug application (NDA) with the US Food and Drug Administration (FDA) for investigational, long-acting, injectable cabotegravir for the prevention of HIV, also called pre-exposure prophylaxis, or PrEP.  

August 7, 2020 Off By Dino Mustafić

The FDA approved an expanded indication of ViiV Healthcare’s Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1 with no history of treatment failure or resistance to Dovato’s components.