EU validates filing of cabotegravir long-acting injectable for HIV.- ViiV Healthcare
ViiV Healthcare announced that the European Medicines Agency (EMA) has validated the company’s marketing authorisation application (MAA) seeking approval of cabotegravir long-acting injectable for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1. Cabotegravir long-acting for HIV prevention is administered six times per year, after initiation.
Submission to the EMA was supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV. The studies demonstrated that cabotegravir long-acting for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with clinical trial participants experiencing a 69% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083, and a 90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084.
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