GSK PLC on Monday said ViiV Healthcare’s cabotegravir for HIV prevention has received a positive opinion by the European Medicines Agency for marketing authorisation.
ViiV Healthcare is a specialist HIV company with GSK as a majority shareholder, alongside shareholders Pfizer Inc and Shionogi & Co Ltd. GSK is a Brentford, London-based pharmaceutical company.
GSK said that cabotegravir has received a positive opinion by the EMA committee for medical products for human use recommending marketing authorisation for cabotegravir long-acting injectable and tablets for HIV prevention.
‘Cabotegravir long-acting for HIV prevention is the first and only long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition,’ GSK said.
Cabotegravir is recommended in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents weighing at least 35 kilograms.
GSK said that the positive opinion is 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 LA for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of acquiring HIV.
‘In 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,’ GSK said.
‘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.’
Cabotegravir LA for PrEP is currently approved for use in the US, Australia, Zimbabwe, South Africa, Malawi, Botswana, and Brazil as Apretude. Submission to other regulatory agencies is on-going.
GSK shares down 0.2% at 1,385.90 pence early Monday in London.
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