Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Complete Medical Communications (CMC)

CMC is a leading global agency dedicated to healthcare communications across the lifecycle. We combine scientific acumen, excellence in delivery...

Latest intelligence

Cell and gene therapy
Tackling the manufacturing cost and complexity challenges...
2019: CRISPR and therapeutic gene editing comes of age
Can gene-editing deliver safe and effective therapeutics for patients with intractable diseases?...
The 10-year Web Challenge
Understanding your users’ needs is more critical online today than ever. A site should mould itself around these insights, deliver those needs quickly, efficiently and with plenty of white space....

Infographics