GlaxoSmithKline PLC ViiV submits HIV 2DR regulatory application to EMA

GlaxoSmithKline plc

GlaxoSmithKline PLC (LON:GSK) noted the following announcement.

ViiV Healthcare announced today submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection.

The submission is based on the global GEMINI 1 & 2 studies that included more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/mL. The results of these studies were presented at the 2018 International AIDS Society meeting in July.

Deborah Waterhouse, CEO ViiV Healthcare said, “We continue to demonstrate our commitment as a company to developing new medicines for people living with HIV and providing options for reducing the number of medicines they will have to take as part of life-long treatment. This regulatory submission, if approved, will make available a two-drug regimen option with dolutegravir and lamivudine instead of the traditional three-drug regimen and is an important step in the evolution of HIV treatment.”

John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, said, “We want to make HIV a smaller part of people’s lives throughout their treatment journey and are committed to challenging the status quo with innovations that are based on our belief that no one should take more medicines than they need. If approved, a single-tablet, 2-drug regimen of dolutegravir and lamivudine would mark a new era in HIV treatment for people newly diagnosed with HIV.”

A new drug application (NDA) to the US FDA is planned for this single tablet regimen for October, using a priority review voucher. Other global regulatory submissions of dolutegravir and lamivudine as a single-tablet, two-drug regimen for HIV-1 therapy are anticipated in the coming months.

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