Business
Cabotegravir LA for PrEP receives positive CHMP
Cabotegravir LA for PrEP receives positive CHMP.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 24 July 2023, London UK\n \nViiV Healthcare's cabotegravir for HIV prevention receives positive CHMP opinion from European Medicines Agency\n \n· Cabotegravir is the first and only long-acting injectable option for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1\n· Positive opinion is based on results from the HPTN 083 and 084 phase IIb/III studies in which the medicine, given as few as six times per year, demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition1,2,3,4\n· With approximately 100,000 people in Europe newly diagnosed with HIV each year5, this is an important step towards expanding HIV prevention options in the region\n \n \n\nGSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, welcomed a positive opinion by 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 safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents weighing at least 35 kg.\n \nIn Europe, strong progress has been made in the delivery of HIV treatment and prevention services, seeing a continuous decline in the incidence of new HIV cases. However, with approximately 100,000 new diagnoses each year, if approved, cabotegravir LA will be the only prevention option for people at risk of HIV acquisition that is administered as few as six times per year.5\n \nKimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: \"The expansion of prevention options is critical if we are to end the HIV epidemic. Long-acting 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 p...