GSK : ViiV's Cabotegravir For HIV Prevention Receives Positive CHMP Opinion From EMA

(RTTNews) - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for cabotegravir long-acting injectable and tablets for HIV prevention, GSK plc. (GSK, GSK.L) said in a statement.

The positive opinion was 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 acquisition.

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.

Cabotegravir long-acting 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.

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