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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 | |||||||||||||||||||||||||||||||||||
By: PR Newswire Association LLC. - 22 Nov 2017 | Back to overview list |
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LONDON, Nov. 21, 2017 /PRNewswire/ -- 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 (CAR 485/511 [95%], dolutegravir + rilpivirine 486/513 [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. Notes to editors About HIV HIV has largely become a chronic treatable disease, with improved access to antiretroviral treatment leading to a 22% drop in global HIV mortality between 2009 and 2013,3 but more can be done for the estimated 36.7 million people living with HIV and 1.8 million individuals newly infected each year worldwide.4 About Juluca Two essential steps in the HIV life cycle include reverse transcription – when the virus turns its RNA (ribonucleic acid) copy into DNA (deoxyribonucleic acid) – and integration – the moment when viral DNA becomes part of the host cell's DNA. These processes require two enzymes called nucleoside reverse transcriptase and integrase. NNRTIs and INSTIs interfere with the action of these two enzymes to prevent the virus from replicating. This decrease in replication can lead to less virus being available to cause subsequent infection of uninfected cells. Juluca was approved by the US Food and Drug Administration (FDA) on 21st November 2017, as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca. Juluca is expected to be available in pharmacies in the US from 11th December 2017. ViiV Healthcare has also submitted regulatory marketing applications in Europe, Canada, Australia and Switzerland. About the SWORD phase III program for dolutegravir (Tivicay®) and rilpivirine (Edurant®) The primary endpoint is the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at Week 48. Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The studies also include exploratory measures to assess change in health-related quality of life, willingness to switch and adherence to treatment regimens. For more information on the trials please visit: www.clinicaltrials.gov Juluca and Tivicay are registered trademarks of the ViiV Healthcare group of companies. *Edurant is a registered trademark of Janssen Sciences Ireland UC. HIGHLIGHTS OF PRESCRIBING INFORMATION JULUCA (dolutegravir and rilpivirine) tablets, for oral use Initial U.S. Approval: 2017 INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-888-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
About ViiV Healthcare For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com. About GSK
References
View original content with multimedia:http://www.prnewswire.com/news-releases/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-300560684.html SOURCE ViiV Healthcare |
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