Latest major approval for Juluca

21 May 2018

ViiV Healthcare and Janssen have received the nod from the European Commission (EC) for the first two-drug regimen, once-daily, single-pill for HIV.

UK-based company ViiV, which specializes in HIV and is majority-owned by the London-based pharma major GlaxoSmithKline (LSE: GSK), has announced the marketing authorization for Juluca (dolutegravir 50mg/rilpivirine 25mg) for HIV1 in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.

Juluca is a two-drug regimen of ViiV’s dolutegravir, the most widely prescribed integrase inhibitor worldwide, and rilpivirine, a second-generation non-nucleoside reverse transcriptase inhibitor marketed under the name Edurant by Janssen, part of the Johnson & Johnson (NYSE: JNJ) group.

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