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Janssen wins European approval for Symtuza

European Commission approves the drug to treat HIV-1

JanssenThe European Commission (EC) has approved Janssen’s Symtuza (darunavir-STR) to treat adults with human immunodeficiency virus type 1 (HIV-1).

It’s the first complete, single-tablet regimen (STR) based on its big-selling protease inhibitor Prezista (darunavir), which it combines with cobicistat, emtricitabine and tenofovir alafenamide (TAF).

Dr Frank Wiegand, medical director, Janssen UK, said: “The decision by the European Commission to approve the use of darunavir-STR validates our efforts to treat HIV more simply, addressing the issues of adherence and resistance.

“We are committed to developing effective and innovative treatments which address these issues, while helping all those living with HIV to achieve an undetectable viral load and ultimately enjoying an improved quality of life.”

Results from a bioequivalence study that compared darunavir-STR with the combined administration of the separate agents darunavir, cobicistate and emtricitabine/tenofovir alafenamide paved the way for the decision from European regulators.

The study 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.

Janssen can now market Symtuza in all countries in the European Union and the European Economic Area, where it will be vying to compete with therapies from GlaxoSmithKline's ViiV unit.

Article by
Gemma Jones

26th September 2017

From: Regulatory



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