GlaxoSmithKline's JV ViiV Healthcare receives regulatory approval for HIV treatment from US authorities
Source - SMW
GlaxoSmithKline said its ViiV Healthcare joint venture with Pfizer received regulatory approval for its two-drug treatment for HIV from the US Food and Drug Administration.
Dovato, a two-drug regimen, reduced exposure to the number of antiretrovirals from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional dolutegravir-based three-drug regimen, the company said.
The approval of Dovato was supported by the global Gemini 1 and 2 studies, in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based (DTG), traditional, three-drug regimen through 48 weeks, with no cases of resistance.
DTG/3TC as a complete, once-daily, single-tablet, two-drug regimen for HIV-1 therapy was currently under review by the European Medicines Agency (EMA) and regulatory authorities in Canada, Australia, Switzerland, and South Africa and several additional submissions were planned throughout 2019, the company said.