The US Food and Drug Administration (FDA) has granted approval to Janssen Pharmaceutical Companies’ single-tablet regimen Symtuza to treat human immunodeficiency virus type 1 (HIV-1).
The drug has been indicated for treatment-naïve patients and some virologically suppressed adults.
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Symtuza is a prescription medicine consisting of 800mg darunavir, 150mg cobicistat, 200mg emtricitabine and 10mg tenofovir alafenamide (TAF).
Cobicistat, emtricitabine and tenofovir alafenamide are provided by Gilead Sciences under a licensing agreement with Janssen.
The single-tablet regimen is said to combine darunavir’s durability and high barrier to drug resistance with favourable safety profile of TAF.
However, the drug comes with a boxed warning for the risk of acute hepatitis B exacerbation following the treatment.
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By GlobalDataJanssen Pharmaceutica Infectious Diseases, Late Development global head Brian Woodfall said: “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.
“We will continue our efforts to advance treatment and remain steadfast in our pursuit of fulfilling the dream of a preventive HIV vaccine.”
The FDA approval is based on results from the AMBER and EMERALD clinical trials designed to evaluate the safety and efficacy of Symtuza when compared to a control regimen in adults without previous antiretroviral (ARV) history and those who are virologically suppressed, respectively.
Data from these 48-week, non-inferiority, pivotal phase III trials showed the single-tablet regimen to be well-tolerated and effective; up to 95% of participants achieved or maintained virologic suppression.
Janssen already secured European Commission and Health Canada approval for the use of Symtuza to treat HIV-1 in adults and adolescents aged 12 years and above having body weight of at least 40kg.
The company intends to submit regulatory filings to gain approval in other markets, along with additional trial findings such as data from the ongoing Phase III DIAMOND rapid initiation study.
