Janssen’s Symtuza scores approval with the FDA in HIV-1

pharmafile | July 18, 2018 | News story | Sales and Marketing HIV, Janssen, Symtuza, pharma 

Janssen has announced that Symtuza (D/C/F/TAF) has received approval from the FDA in the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically supressed adult patients, making it the first and only darunavir-based single-tablet regimen available for the disease.

The US regulator reached the decision after reviewing Phase 3 data from two 48-week-long studies which showed that 95% of participants receiving the drug achieved virologic suppression. The data also revealed that the drug was well-tolerated, but nevertheless the FDA has stipulated that the packaging for Symtuza must carry a warning on the possible risk of acute post-treatment 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,” commented Dr Joseph Eron, Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research. “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.

He added: “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.”

The decision follows in the steps of the European Commission, who gave the go-ahead for the drug’s use back in September last year. Canada also approved the treatment in April this year.

“For more than 25 years, Janssen has been committed to the research and development of transformational medical innovation across the continuum of HIV care,” remarked Dr Brian Woodfall, Global Head of Late Development, Infectious Diseases at Janssen. “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. 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.”

Matt Fellows

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