EMA will consider an application for the registration of an antiviral drug dolutegravir / lamivudine
September 14, became known that the pharmaceutical company ViiV Healthcare, part of the GlaxoSmithKline structure, applied to the European Medicines Agency (EMA) for the registration of a two-component antiretroviral dolutegravir / lamivudine intended for the treatment of patients with HIV-1.
As reported by the portal PharmaTimes, the basis for filing documents for registration were the recently announced results of the GEMINI 1 and 2 studies, which managed to confirm the efficacy of the drug comparable with the three-component scheme.
The developers of the combination explain that the overall rate of patients who achieved undetectable viral load in studies exceeded 90%.
At the same time, the number of those who stopped taking therapy against the background of side effects did not exceed 2%. At the same time, as stressed in ViiV, the number of undesirable reactions in dolutegravir / lamivudine patients was significantly less than in cases with three components (18% and 24%, respectively).
We add that ViiV confirmed its intention to apply for registration of the drug in the US in October. The developer is counting on an accelerated procedure.