Breaking News
October 17, 2018 - Health Tip: Know the Risks of Chicken Pox
October 17, 2018 - Immunotherapy effective against hereditary melanoma
October 17, 2018 - Researchers reveal new mechanism for how animal cells stay intact | News Center
October 17, 2018 - Alzheimer's Goes Under the Cryo-Electron Microscope
October 17, 2018 - Medicare for all? CMS chief warns program has enough problems already
October 17, 2018 - Metrohm Raman introduces Mira P handheld Raman system
October 17, 2018 - Expanding the knowledge about hippocampus to better understand cognitive deficits in MS
October 17, 2018 - Study of Nigerian breast cancer patients reveals prevalence of aggressive molecular features
October 17, 2018 - Many healthy children may have metabolic risk factors, finds study
October 17, 2018 - A new antibiotic could be a better, faster treatment for tuberculosis
October 17, 2018 - “I will not become a Robot Doctor”: A medical student vows to practice compassion
October 17, 2018 - Study findings may explain sporadic outbreaks of C. difficile infections in hospitals
October 17, 2018 - Purdue researchers develop new chemical process to find better drug ‘fits’ for patients
October 17, 2018 - Yale researchers develop way to attack RNA with small-molecule drugs
October 17, 2018 - New pragmatic study launched to understand the effectiveness of new type 2 diabetes drug
October 17, 2018 - Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
October 17, 2018 - Nine cases of polio-like illness suspected in children in illinois
October 17, 2018 - Eisai enters into agreement with Eurofarma for development and sales of lorcaserin in 17 countries
October 17, 2018 - Patients once thought incurable can benefit from high-dose radiation therapy
October 17, 2018 - Researchers awarded grant to advance testing of experimental heroin vaccine
October 17, 2018 - Researchers examine SSRI use during pregnancy and major gestational malformations
October 17, 2018 - Study reveals link between childhood abuse and higher arthritis risk in adulthood
October 17, 2018 - Research shows people over 65 are not performing enough physical activity
October 17, 2018 - FDA Approves Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
October 17, 2018 - Weight gain after smoking cessation linked to increased short-term diabetes risk
October 17, 2018 - Researchers find opportunity to control salt-sensitive hypertension without exercising
October 17, 2018 - Women not warned about cancer associated with breast implants
October 17, 2018 - Metrohm offers robust handheld Raman analyzer for Defense and Security
October 17, 2018 - Modeling Non-Numerical Data in Systems Biology
October 17, 2018 - Research aims to address health disparities in African-American men
October 17, 2018 - Human and cattle decoys trap outdoor-biting mosquitoes in malaria endemic regions
October 17, 2018 - High Circulating Prolactin Level Inversely Linked to T2DM Risk
October 17, 2018 - Study finds gene variant predisposes people to both Type 2 diabetes and low body weight
October 17, 2018 - Metrohm software products make it easy to comply with ALOCA and ALCOA+ guidelines
October 17, 2018 - Network of doctors identify the cause of 31 new conditions
October 17, 2018 - Notable improvement in brain cancer survival among younger patients but not much for elderly
October 17, 2018 - Scientists shed light on roles of transcription factors, TP63 and SOX2, in squamous cell carcinoma
October 17, 2018 - Costs of Medicare Diabetes Prevention Program may be higher than expected reimbursement
October 17, 2018 - Misuse of prescription opioids or benzodiazepines associated with suicidal thoughts
October 17, 2018 - New research seeks to address sex disparities in women’s health
October 17, 2018 - C-Section Rates Have Nearly Doubled Since 2000: Study
October 17, 2018 - Talking to Your Kids About STDs
October 17, 2018 - New classification of periodontal and peri-implant diseases and conditions
October 17, 2018 - Herbert D. Kleber, Pioneer in Addiction Treatment, Dies at 84
October 17, 2018 - Health effects of smoke-filled atmosphere
October 17, 2018 - Down syndrome may hold important clues to onset of Alzheimer’s disease
October 17, 2018 - A special report on US’ aging societies
October 17, 2018 - Birth mode may have acute effects on neurodevelopment, study suggests
October 17, 2018 - Global health innovation system fails to deliver affordable treatments to patients, says report
October 17, 2018 - Simple, inexpensive test quickly detects antibiotic-resistant ‘superbugs’
October 17, 2018 - New drugs could reduce risk of heart disease when added to statins
October 17, 2018 - Visible and valued: Stanford Medicine’s first-ever LGBTQ+ Forum
October 17, 2018 - HVP vaccination not linked with rise in teen risky sex
October 17, 2018 - Potential ‘early warning markers’ for sepsis discovered
October 17, 2018 - Who knew? Life begins (again) at 65
October 17, 2018 - Application of blood pressure guidelines ups treatment
October 17, 2018 - Stanford researchers find that small molecule may help treat enzyme deficiency
October 17, 2018 - Speed Cameras Save Money and Lives in New York City
October 17, 2018 - Men who conform to ‘the man box’ more likely to consider suicide and violence
October 17, 2018 - Researchers aim to create more authentic organoids for drug testing, transplantation
October 16, 2018 - New blood test for pediatric brain tumor patients offers safer approach than surgical biopsies
October 16, 2018 - Age-related estrogen increase may be the culprit behind inguinal hernias in men
October 16, 2018 - Skills-Based Intervention Did Not Cut Systolic BP After Stroke, TIA
October 16, 2018 - Researchers uncover new role of TIP60 protein in controlling tumour formation
October 16, 2018 - Behind the scenes of a lifesaving heart surgery
October 16, 2018 - ‘To See the Suffering’
October 16, 2018 - Drinking concentrated rosemary extract can boost memory by up to 15%, shows research
October 16, 2018 - Medicare Advantage riding high as new insurers flock to sell to seniors
October 16, 2018 - NHS tackles prescription fraud to save millions
October 16, 2018 - New molecular switch may help develop sophisticated photomedications
October 16, 2018 - Improving access to behavioral health screenings for pregnant and postpartum women
October 16, 2018 - Health Highlights: Oct. 12, 2018
October 16, 2018 - Study holds promise for new pediatric brain tumor treatment
October 16, 2018 - Patient advocate uses MRI scans to create art and spark conversations about life with illness
October 16, 2018 - Fish oil based diets may suppress growth and spread of breast cancer cells
October 16, 2018 - Number of VHA facilities offering acupuncture has increased rapidly
October 16, 2018 - Influential Leapfrog Group jumps in to rate 5,600 surgery centers
October 16, 2018 - HIV-infected infants more likely to acquire congenital cytomegalovirus infection
October 16, 2018 - Study pinpoints new marker that can predict Crohn’s disease subtype
October 16, 2018 - Simple procedure could be efficacious intervention for failed back surgery
FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection

FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection

image_pdfDownload PDFimage_print

FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection

TITUSVILLE, N.J, JULY 17, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide – D/C/F/TAF), the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. Symtuza combines the proven high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of an STR. Symtuza has a Boxed Warning regarding the risk of post-treatment acute exacerbation of hepatitis B.

“As clinicians, we may not always have the full picture of a patient’s health or their risk for developing resistance when making treatment decisions. In key Phase 3 clinical trials, Symtuza successfully treated those who were starting therapy, as well as those who were stably suppressed on antiretroviral (ARV) therapy – including patients with more complex treatment histories or previous virologic failure – demonstrating its potential as an important new treatment option for a wide variety of patients,” said Joseph Eron, M.D., Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, N.C.

The U.S. Department of Health and Human Services guidelines1 recommend darunavir-based therapies for treatment-naïve patients in certain clinical situations, including when a person may have uncertain adherence or when ARV treatment should be initiated before resistance test results are available.

“Many people living with HIV struggle to adhere to their medication, which can lead to the development of drug resistance and potentially cause their medication – or even an entire class of medications – to stop working,” continued Dr. Eron.

Symtuza received FDA approval based on data from two 48-week, non-inferiority, pivotal Phase 3 studies that assessed the safety and efficacy of Symtuza versus a control regimen in adults with no prior ARV history (AMBER) and in virologically suppressed adults (EMERALD). Results from both trials demonstrated that Symtuza was effective and well-tolerated, with up to 95 percent achieving or maintaining virologic suppression (HIV-1 RNA

  • AMBER compared Symtuza to darunavir/cobicistat (D/C) plus emtricitabine/tenofovir disoproxil fumarate (F/TDF). The results, presented at the 16th European AIDS Conference in October 2017, demonstrated similar viral suppression rates (HIV-1 RNA
  • The EMERALD study, presented at IDWeek in October 2017, compared Symtuza to continuing treatment with a boosted protease inhibitor (bPI) plus emtricitabine and TDF. The trial found there were low virologic failure rates (HIV-1 RNA ≥50 c/mL; 0.8% vs. 0.5%) and high virologic suppression rates (HIV-1 RNA

    “For more than 25 years, Janssen has been committed to the research and development of transformational medical innovation across the continuum of HIV care. The FDA approval of Symtuza marks another important milestone in our quest to address real-world clinical challenges, combat HIV drug resistance and meet the diverse needs of those living with HIV,” said Brian Woodfall, M.D., Global Head of Late Development, Infectious Diseases, Janssen Pharmaceutica NV. “There is more to be done in our fight to make HIV history, and we will not stop here. We will continue our efforts to advance treatment and remain steadfast in our pursuit of fulfilling the dream of a preventive HIV vaccine.”

    The recommended dosage of Symtuza is one tablet taken once-daily with food. Symtuza is not recommended in patients with creatinine clearance below 30 mL per minute or those with severe hepatic impairment.

    According to the Prescribing Information, prior to or when initiating treatment with Symtuza, patients should be tested for hepatitis B virus (HBV) infection and renal function, and renal function should be monitored as clinically appropriate during therapy. See below for Important Safety Information.

    Symtuza has also been approved by the European Commission (EC) and Health Canada for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg. European approval allows Janssen to market Symtuza in all member states of the European Union and the European Economic Area. Janssen plans additional regulatory filings in other markets worldwide, and additional Symtuza data, including data from an ongoing Phase 3 rapid initiation study (DIAMOND) will be presented at AIDS 2018 in Amsterdam, The Netherlands in late July.

    Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences, Inc.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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.

    Janssen Therapeutics, Division of Janssen Products, LP will market Symtuza in the United States. Both Janssen Products, LP and Janssen Pharmaceutica NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

    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 of Symtuza 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 research and 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; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions 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 December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements,” and “Item 1A.” Risk Factors, and in the company’s subsequent Quarterly Reports on Form 10-Q and other 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 nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Source: Janssen Pharmaceuticals, Inc.

    Posted: July 2018

    Related Articles:

    Symtuza (cobicistat, darunavir, emtricitabine and tenofovir alafenamide) FDA Approval History

  • Tagged with:

    About author

    Related Articles