GSK’s HIV drug Dovato gets FDA approval

The U.S. Food and Drug Administration (FDA) has announced the approval of the first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment.

GlaxoSmithKline’s Dovato (dolutegravir and lamivudine) has been indicated as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to either dolutegravir or lamivudine.

The approval was based on the Gemini I and II studies, which included more than 1,400 patients infected with HIV-1, showed Dovato to be as effective as the standard three-drug regimen.

It reduces exposure to the number of ARVs from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional dolutegravir-based three-drug regimen.

"Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug," said Debra Birnkrant, M.D., director of the Division of Antiviral Products.

She continued, "Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time."

One new person contracts HIV in the U.S. every 13 minutes. Approximately 1.1 million people in the U.S. are living with HIV, but about 15% of them (1 in 7) are unaware they are infected.

by Anna Smith

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