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FDA Approves Symtuza

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 <50c/mL).

  • 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 <50c/mL at 48 weeks – per FDA Snapshot analysis) between the darunavir-based STR vs. control (91.4% vs 88.4% respectively) and low virologic failure rates (HIV-1 RNA ≥50 c/mL; 4.4% vs. 3.3%) at 48 weeks. Symtuza also showed less bone loss (in a sub-study) and a significant improvement in markers of renal function versus control. The long-term clinical significance of these bone mineral density (BMD) changes is not known. Overall, Symtuza was well-tolerated, with fewer discontinuations due to an adverse event (AE; 2% vs. 4%) versus control, only one grade 3 adverse reaction and no grade 4 adverse reactions. The most frequent adverse reactions reported in ≥2% of subjects were diarrhea, rash, nausea, fatigue, headache, abdominal discomfort and flatulence.
  • 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 <50 c/mL; 94.9% vs. 93.7%) according to FDA Snapshot analysis at Week 48, with no patients discontinuing the study due to virologic failure. Switching to Symtuza demonstrated improvement in BMD (in a sub-study) and a significant improvement in some markers of renal function versus control. The long-term clinical significance of these BMD changes is not known. The safety profile was similar to that of those patients with no prior ARV treatment history, and the percentage of participants who discontinued due to AEs, regardless of severity, was 1%.

“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

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