GSK : EC Authorizes ViiV Healthcare's Apretude For HIV Prevention

(RTTNews) - The European Commission has authorized ViiV Healthcare's Apretude (cabotegravir long-acting injectable and tablets) for HIV prevention, GSK plc (GSK,GSK.L) said in a statement on Tuesday.

Cabotegravir is indicated 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 (at least 12 years of age), weighing at least 35 kg.

Cabotegravir long-acting injectable and tablets for PrEP is the first and only HIV prevention option approved in the European Union that reduces the number of doses needed for effective HIV prevention from 365 daily pills to as few as six injections per year.

According to the company, Cabotegravir long-acting injectable and tablets for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in reducing the risk of HIV acquisition in clinical trials.

Cabotegravir long-acting for PrEP is approved for use in the US, Australia, South Africa, as well as other countries as Apretude. Submission to other regulatory agencies is on-going.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK and Pfizer (PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention options.

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