ViiV HEALTHCARE ANNOUNCES US FDA APPROVAL FOR JULUCA®

Juluca® ( dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection

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 dolutegravir 50mg (ViiV Healthcare), an integrase strand transfer inhibitor and rilpivirine 25mg (Janssen Therapeutics, Division of Janssen Products LP), a non-nucleoside reverse transcriptase inhibitor.

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 ( dolutegravir + rilpivirine 486/513 [95%], CAR 485/511 [95%], [adjusted difference -0.2% (95% confidence interval CI: -3.0%, 2.5%), pooled analysis]).2 Virologic suppression rates were similar between treatment arms.2 Drug related adverse events and adverse events leading to withdrawal occurred in low frequencies in both arms of the study, but more frequently in the investigational arm.

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 dolutegravir . Juluca, our new 2-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.”

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 dolutegravir /lamivudine for treatment naïve patients, as well as cabotegravir /rilpivirine long-acting injectable for treatment-experienced and naïve patients.

References

[1] Juluca US label information

[2] 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.