GlaxoSmithKline’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.
“Advances in HIV treatment mean that people living with HIV are living longer, and are taking daily medication over a longer period of time. With our portfolio of two-drug regimens, with dolutegravir at the core, we are establishing a new way of treating HIV which challenges the three-drug regimen standard of care. This means that people living with HIV may take fewer drugs while having the same efficacy outcomes. Today’s CHMP Positive Opinion for Dovato is an important step towards providing treatment-naïve people living with HIV in Europe the first once-daily, single-pill, complete 2-drug regimen for the treatment of HIV,” John C. Pottage, Jr, M.D. Chief Scientific Medical Officer, ViiV Healthcare, said after the development.
About Dolutegravir
Dolutegravir (Tivicay) is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
About Lamivudine
Lamivudine is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection.
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