GSK’s HIV drug wins European panel thumbs-up
(Reuters) – GlaxoSmithKline Plc’s two-drug treatment for HIV infections won marketing approval from a European Medicines Agency (EMA) panel on Friday, after the British drugmaker received a nod from the U.S. Food and Drug Administration earlier this month.
EMA’s human medicines committee (CHMP) cleared the combination of dolutegravir and lamivudine, to be branded as Dovato, for treating newly diagnosed adults, boosting GSK’s growth prospects against competitors.
Last year, the company showed in drug trials that the once-a-day Dovato pill was as good as a standard three-drug cocktail in suppressing the virus that causes AIDS and also in terms of tolerability.
While final approvals are up to the European Commission, it generally follows the CHMP’s recommendation and endorses them within a couple of months.
(Reporting by Tanishaa Nadkar and Justin George Varghese in Bengaluru; Editing by James Emmanuel)