ViiV HEALTHCARE ANNOUNCES US FDA APPROVAL FOR JULUCA®
London, 21 November 2017 – ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.1
Juluca is the first 2-drug regimen (2DR) comprising
Deborah Waterhouse, CEO ViiV Healthcare said, “The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”
This FDA approval is based primarily upon data from two pivotal phase III clinical trials, SWORD-12 and SWORD-2,2 which showed the 2-drug regimen achieved non-inferior viral suppression (HIV-1 RNA less than 50 copies per mL) at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive 2-drug regimen research and development programme built around the characteristics of
Juluca is the first medicine in our 2-drug regimen pipeline, which looks to help lessen the lifetime burden of treatment for people living with HIV. Our R&D efforts are exploring the potential of two further 2-drug regimens both in phase III development, a once-daily, single pill containing
 Juluca US label information
 Llibre JM, Hung C-C, Brinson C, et al. SWORD 1 & 2: Switch to DTG + RPV maintains virologic suppression through 48 weeks, a Phase III study. Presented at: Conference on Retroviruses and Opportunistic Infections; February 13-16, 2017; Seattle, WA, USA.
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