ViiV Healthcare gains positive CHMP opinion for cabotegravir for HIV prevention
GSK has announced that ViiV Healthcare has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention.
Cabotegravir is recommended in combination with safe sex practices as a pre-exposure prophylaxis (PrEP) with the aim of reducing the risk of sexually acquired HIV-1 infection in high risk adults and adolescents who weigh over 35kg.
This decision is based on data from two phase 2b/3 muticentre, randomised, double-blind, active controlled studies, which assessed the drug’s safety and efficacy as PrEP for HIV-negative men who have sex with men, transgender women and cisgender women who were at an increased risk of contracting HIV.
Kimberly Smith, MD, head of research and development at ViiV Healthcare, commented: “The expansion of prevention options is critical if we are to end the HIV epidemic. LA options have the potential to play an important role in reducing challenges such as inconsistent adherence to taking daily pills, and stigma associated with oral PrEP use that can be faced by people who could benefit from PrEP. At ViiV Healthcare we are at the forefront of cutting-edge science, developing innovative solutions to address the biggest unmet needs in HIV prevention. With the CHMP positive opinion, we are hopeful that people in Europe will soon be able to benefit from greater choice.”
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