EC approves Janssen’s Symtuza

Janssen-Cilag International has received European approval for its once-daily pill Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to treat patients with human immunodeficiency virus type 1 (HIV-1).

It is the only darunavir-based single tablet regimen (STR) indicated for HIV-1 infection in adults and adolescents aged 12 years and older. STRs have the capacity to boost adherence and reduce the medicine burden for the one million or so people in the European Union currently living with HIV.

The European Commission’s decision comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion in July.

Darunavir is one of the most widely used HIV treatments due to its ability to control the HIV virus and offer a high barrier to resistance. The once-daily STR combines darunavir 800 mg, cobicistat 150 mg and emtricitabine/tenofovir alafenamide 200 mg/10 mg fixed-dose combination.

A Phase III programme investigating the safety and efficacy of this combination is ongoing, but approval was based on a study which found that the STR is bioequivalent to the combined administration of the separate agents, and is well tolerated.
The pivotal Phase III EMERALD trial showed that the once-daily STR also had a high virologic suppression rate at 24 weeks in HIV-1 positive, virologically-suppressed adults who switched from a standard boosted protease inhibitor plus tenofovir/emtricitabine regimen.

"Today’s approval by the European Commission demonstrates our efforts to treat HIV more simply, helping all those living with HIV to achieve an undetectable viral load while enjoying an improved quality of life," said Lawrence M. Blatt, Global Therapeutic Area Head, Janssen Infectious Diseases Therapeutics.

EMERALD 48-week data is due to be presented at ID Week 2017 in San Diego next month.

Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences but Janssen is responsible for the manufacture, registration, distribution and commercialisation of this STR under a worldwide licensing agreement.