GlaxoSmithKline’s ViiV Healthcare venture earns CHMP backing for HIV therapy

GlaxoSmithKline’s joint venture ViiV Healthcare has received a recommendation for EU approval of its newest HIV therapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending marketing authorisation for Juluca for the treatment of HIV in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months, with no history of virological failure and treatment resistance. Juluca is a two drug regimen made up of dolutegravir 50mg [ViiV Healthcare] and rilpivirine 25mg [Janssen Sciences].

This new two-drug regimen consists of dolutegravir and rilpivirine, and has demonstrated its safety and efficacy in a pair of pivotal phase III clinical trials, SWORD-1 and SWORD-2. Juluca has already been approved in the US.

Deborah Waterhouse, chief executive officer at ViiV Healthcare, said: “It takes us a step closer to offering the first, single-pill, two-drug regimen with the opportunity to reduce the number of drugs needed to treat HIV in those who are virologically suppressed.”

ViiV Healthcare is a global specialist HIV company that is majority-owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders.

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