GSK receives EMA nod for HIV treatment Dovato

09-Jul-2019 - Last updated on 09-Jul-2019 at 13:38 GMT

(Image: Getty/spukkato)

After the US FDA approval, GSK's ViiV moves forward by securing entry onto the European market for two-drug HIV treatment Dovato.

ViiV Healthcare, an HIV-focused company, majority owned by GlaxoSmithKline, announced marketing authorisation from the European Medicines Agency (EMA) for Dovato (dolutegravir/lamivudine).

Dovato is indicated for the treatment of patients with HIV-1, aiming to provide a once-daily, single-pill, two-drug regimen whilst enabling the intake of fewer antiretrovirals and thereby avoiding the additional side effects.

Specifically, the product can be prescribed to adults and adolescents above 12 years of age, weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

John Pottage, chief scientific and medical officer at ViiV said that the company aims to “reduce the number of HIV drugs people living with HIV take over a lifetime and Dovato is an important addition to our portfolio of medicines to support this aim.”

ViiV recently received approval for Dovato from the US Food and Drug Administration (FDA), while it has submitted further regulatory applications in Canada, Australia, Switzerland, and South Africa.

The company also markets Juluca (dolutegravir/rilpivirine), a two-drug product for the maintenance treatment of the HIV virus.