TITUSVILLE, N.J., Nov. 21, 2017 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today
JULUCA® is a once-daily, antiretroviral combination of dolutegravir, an integrase strand transfer inhibitor (INSTI) marketed by ViiV Healthcare as TIVICAY®, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Janssen as EDURANT®. With JULUCA®, people living with HIV who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months and have no prior history of treatment failure – and no known resistance to the individual components of JULUCA® – now have a new treatment option to consider.1
"Today's approval of JULUCA® marks a significant milestone in the treatment of HIV," said Brian Woodfall, Global Head of Late Development, Janssen Research & Development. "As the first single-pill, complete two-drug regimen, JULUCA® maintains the safety and efficacy of a traditional three-drug regimen without an N(t)RTI. This is exciting because it offers those living with HIV who are compliant and stably suppressed a new, simplified treatment option to consider."
JULUCA® received FDA approval based on data from the two pivotal Phase 3 SWORD studies, which are identical, randomized, multicenter, open-label, non-inferiority studies designed to assess the safety and efficacy of switching to the two-drug regimen of dolutegravir and rilpivirine compared with remaining on current antiretroviral regimen (CAR). The studies included more than one thousand patients who previously achieved stable viral suppression for at least six months on other antiretroviral regimens (integrase inhibitor, NNRTI, or boosted protease inhibitor-based) and had no history of virologic failure or known resistance to dolutegravir or rilpivirine.2
Reaching and maintaining suppression of viral load is a key treatment goal for people living with HIV. Results demonstrated that JULUCA® achieved non-inferior viral suppression (HIV-1 RNA <50 c/mL) at 48 Weeks compared with a three-drug CAR in both studies (dolutegravir + rilpivirine [DTG+RPV] 486/513 (95%), CAR 485/511 (95%), adjusted difference -0.2%, (95% CI: [2.5%,-3.0%])). Virologic failure rates were <1% in the DTG+RPV arm and 1% in the CAR arm. No INSTI resistance-associated mutations or clinically significant resistance to rilpivirine were reported. The proportion of patients who discontinued treatment due to an adverse event (AE) was 4% in those receiving DTG+RPV once daily and less than 1% in those who remained on their CAR. The most common AEs leading to discontinuation were psychiatric disorders in 2% receiving DTG+RPV and less than 1% on the CAR. The most common AEs (all grades) reported in at least 2% of patients were diarrhea and headache.
Switching to the two-drug regimen of JULUCA® showed a neutral effect on lipids – at 48 Weeks, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and total cholesterol to HDL ratio were similar between the treatment arms. In addition, while the long-term clinical significance of bone mineral density (BMD) changes is not known, a substudy demonstrated mean BMD increased from baseline to Week 48 in people who switched from an antiretroviral treatment (ART) regimen containing tenofovir disoproxil fumarate (TDF) to JULUCA® (1.34% total hip and 1.46% lumbar spine) compared with those who continued on treatment with a TDF-containing ART regimen (0.05% total hip and 0.15% lumbar spine). The SWORD trials are ongoing and planned to continue through 148 Weeks. Future long-term data and analyses will be presented at upcoming medical congresses.
"At Janssen, we strive to advance science and develop new treatments to help those living with HIV better manage their condition and adhere to therapy by simplifying dosing regimens and reducing pill burden," said Rick Nettles, MD, Vice President, US Medical Affairs, Janssen Infectious Diseases. "The FDA approval of JULUCA®, which is the result of a partnership with ViiV Healthcare, exemplifies our continued commitment to meeting the diverse needs of the HIV community."
To learn more about Janssen's commitment to the prevention and treatment of HIV, please visit jnj.com/HIV.
Notes to editorsIn June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson announced a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single tablet in order to expand the treatment options available to people living with HIV.
About JULUCA®JULUCA® is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral 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
ViiV Healthcare has also submitted regulatory marketing applications in Europe, Canada, Australia and Switzerland. Outside of the U.S., the two-drug regimen of dolutegravir and rilpivirine is an investigational product and is currently still under review.
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use JULUCA safely and effectively. See full prescribing information for JULUCA.
JULUCA (dolutegravir and rilpivirine) tablets, for oral use Initial U.S. Approval: 2017INDICATIONS AND USAGEJULUCA, a two-drug combination of dolutegravir, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those 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.
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSEach tablet contains: 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride).
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSThe most common adverse reactions (all Grades) observed in at least 2% of subjects were diarrhoea and headache.
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.
USE IN SPECIFIC POPULATIONSLactation: Breastfeeding is not recommended due to the potential for HIV transmission.
About the Janssen Pharmaceutical Companies At Janssen, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal.
Tivicay® is a registered trademark of the ViiV Healthcare group of companies.
EDURANT® is a registered trademark of Janssen Sciences Ireland UC.
EDURANT® (rilpivirine), in combination with other antiretroviral agents, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naďve patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
The following points should be considered when initiating therapy with EDURANT®:
EDURANT® is not recommended for patients less than 12 years of age.
Important Safety Information
Warnings and Precautions
This is not a complete list of potential drug interactions.
Please see full Prescribing Information for more details.
Use in Specific Populations
Please see full Prescribing Information for more details.
TIVICAY (dolutegravir) tablets
Important Safety Information for TIVICAY® (dolutegravir) 10-, 25-, and 50-mg tablets, for oral use
The following Important Safety Information (ISI) is based on the Highlights section of the US Prescribing Information for TIVICAY and local variations apply. Please consult the full Prescribing Information for all the labeled safety information for TIVICAY or please refer to applicable local labelling.
FDA INDICATIONS AND USAGE
TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.
Limitations of Use:
WARNINGS AND PRECAUTIONS
The most common adverse reactions of moderate to severe intensity and incidence at least 2% (in those receiving TIVICAY in any one adult trial) are insomnia, fatigue, and headache.
USE IN SPECIFIC POPULATIONS
Please visit the following link for the full US prescribing and patient information: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF#page=1
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development and benefits of new treatment options for HIV-1. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Therapeutics, Division of Janssen Products, LP, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under "Item 1A. Risk Factors," its most recently filed Quarterly Report on Form 10-Q, including under the caption "Cautionary Note Regarding Forward-Looking Statements," and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
MEDIA CONTACT:Rebecca Genin+1 [email protected]
Kristina Chang+1 [email protected]
Katie Buckley+44 7971 956 [email protected]
INVESTOR RELATIONS: Lesley Fishman+1 732-524-3922
Joseph J. Wolk+1 732-524-1142
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SOURCE Janssen Therapeutics
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