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Home Industry News GlaxoSmithKline’s ViiV Healthcare receives CHMP backing for new Tivicay indication

GlaxoSmithKline’s ViiV Healthcare receives CHMP backing for new Tivicay indication

20th December 2016

GlaxoSmithKline's specialist HIV business ViiV Healthcare has announced that its drug Tivicay has been recommended for EU regulatory approval in a new indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Type II variation and extension applications to reduce Tivicay's weight and age limit for the treatment of HIV in children and adolescents.

This would bring down the weight limit from 40 kg to 15 kg in patients aged six to 12 years old, while also allowing the company to register new dose strengths of 10 mg and 25 mg oral tablets.

Data from the phase I/II P1093 study, which assessed the safety and efficacy of the drug plus an optimised background regimen in children and adolescents infected with HIV-1 in age-defined cohorts, was used to support this application.

Dr John Pottage Jr, chief scientific and medical officer of ViiV Healthcare, said: "Through our research and development efforts, we are committed to further investigating the potential of dolutegravir in younger age-groups and fulfil our promise to leave no patient behind."

ViiV Healthcare was established in November 2009 by GlaxoSmithKline and Pfizer, with Shionogi joining the collaboration in October 2012.

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