ViiV Healthcare Receives EMA’s CHMP Positive Opinion of Cabotegravir for HIV Prevention
Shots:
- The EMA’s CHMP has adopted the positive opinion recommending marketing authorization for cabotegravir long-acting (LA) injectable and tablets for HIV prevention
- The positive opinion was based on the 2 international P-IIb/III studies (HPTN 083 & 084) evaluating cabotegravir (q8w) for PrEP in HIV- men who have sex with men, transgender women & cisgender women who were at increased risk of acquiring HIV
- The studies showed that cabotegravir LA for PrEP was superior to emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with 69% & 90% lower rates of HIV acquisition over FTC/TDF tablets in (HPTN 083) & (HPTN 084) studies. Cabotegravir for PrEP was approved in the US, Australia, Zimbabwe, South Africa, Malawi, Botswana & Brazil as Apretude
Ref: GSK | Image: ViiV
Related News:- ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) Receives the US FDA’s Approval for Virologically Suppressed Adolescents with HIV
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