Janssen Announces US FDA Approval of HIV-1 Treatment Drug

On Jul 18, 2018

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, a 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. See below for Important Safety Information.

“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 16^th 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.

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