Beerse, Belgium: Janssen-Cilag International NV (Janssen) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for SYMTUZA™ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), a once-daily darunavir-based single tablet regimen (STR).
If approved, it will be the only darunavir-based STR indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg, with genotypic testing guiding use. This STR combines the proven efficacy and durability of darunavir with the improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (tenofovir disoproxil fumarate), and will be the only treatment that could deliver the adherence advantages of a STR coupled with the high genetic barrier to resistance that darunavir offers.
“Darunavir is one of the most widely used HIV treatments in the European Union due to its ability to control the HIV virus while offering a high barrier to resistance. We will now be able to combine a complete darunavir-based HIV treatment regimen into a once daily tablet. We are extremely excited to be one step closer to getting this therapy to people living with HIV and in doing so hope to reduce the treatment burden faced by many living with the virus,” said Lawrence M. Blatt, Ph.D., Global Therapeutic Area Head, Janssen Infectious Diseases Therapeutics.
“A darunavir-based STR represents a significant evolution in treatment options for HIV patients,” said Jean-Michel Molina, Professor of Infectious Diseases at the University of Paris Diderot. “With around two million people in Europe currently managing their HIV, this is a true advancement in helping patients achieve an undetectable viral load and improving quality of life. Reducing the pill burden allows people greater freedom and flexibility, and through this we may also improve treatment adherence.”
The Positive Opinion is based on a bioequivalence study comparing the once-daily STR with the combined administration of the separate agents darunavir [D] 800 mg, cobicistat [C] 150 mg, and emtricitabine/tenofovir alafenamide [FTC/TAF] 200 mg/10 mg fixed-dose combination. A Phase 3 clinical trial programme investigating the efficacy and safety of the darunavir-based combination is underway. Data on the bioequivalence study, as well as interim data from the Phase 3 Pivotal EMERALD trial in virologically suppressed antiretroviral therapy (ART) experienced patients, who were switched to the STR, will be presented at the upcoming International AIDS Society (IAS) conference in Paris, France. Further EMERALD 48-week data, and 48-week data from the Phase 3 AMBER trial in ART naïve patients, will be released in due course. Please visit www.jnj.com/HIV for further details on the breadth of science being presented by Johnson & Johnson companies and its partners.
The CHMP’s Positive Opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorisation for medicines in the European Economic Area. The European Commission’s final decision is anticipated in the coming months.
Janssen have brought medicines to market across a range of patient populations that have helped to transform the efficacy and tolerability of treatment. Treatment regimens that combine D/C (REZOLSTA®, Janssen-Cilag International NV, U.S name PREZCOBIX®) and F/TAF (DESCOVY®, Gilead Sciences International Ltd) are currently approved1,2 for the treatment of HIV. SYMTUZA™ is a significant evolution of this approach, combining both treatments in a single, convenient tablet, and is part of Janssen’s broader commitment to develop effective and innovative therapies which address the issues of adherence and resistance.