European Commission approves Janssen’s Symtuza for HIV-1 treatment

The European Commission (EC) has approved Janssen-Cilag International’s Symtuza for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Symtuza is the only once-daily darunavir-based single-tablet regimen (STR) indicated to treat HIV-1 adults and adolescents aged 12 and older with a body weight of at least 40kg in the European Union.

The drug is a fixed-dose combination of four active substances, darunavir, cobicistat, emtricitabine and tenofovir alafenamide (D/C/F/TAF). Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences.

Janssen Infectious Diseases Therapeutics global therapeutic area head Dr Lawrence M. Blatt said: "At Janssen, we are committed to developing effective and innovative treatments which address the issues of adherence and resistance.

"Today’s approval by the EC 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."

The Janssen treatment combines the proven efficacy and durability of darunavir with the enhanced renal laboratory and bone mineral density profile of F / TAF as compared to F / TDF (emtricitabine / tenofovir disoproxil fumarate).

It is currently the only approved treatment to provide the benefits of an STR in addition to the high-genetic barrier to resistance offered by darunavir.

Results from a bioequivalence study that compared Symtuza with the combined administration of the separate agents; darunavir at 800mg, cobicistat at 150mg and emtricitabine / tenofovir alafenamide (FTC / TAF) at a 200mg / 10mg fixed-dose combination, confirmed that the once-daily STR is bioequivalent to the combined administration of the separate agents, as well as demonstrating that the STR is well tolerated.