ViiV Healthcare has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for a tablet of two-drug regimen -- dolutegravir (DTG) and lamivudine (3TC) -- which can treat HIV-1 infections.
The company is a joint venture between GlaxoSmithKline, Pfizer and Shionogi.
ViiV healthcare based its application on the global GEMINI 1 & 2 studies, which included more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/ml.
The company unveiled the result of the studies at the 2018 International AIDS Society meeting in July.
“We have now entered an exciting new era of treatments for people living with HIV. ViiV Healthcare believes that a two-drug regimen has the potential to be an important option for many who may spend their lifetime taking drugs to control their virus,” ViiV Healthcare CEO Deborah Waterhouse said.
This regulatory submission is the next step in the two-drug regimen journey and reinforces the company’s belief that many patients can control their disease with two drugs instead of three or more, she added
John C. Pottage, chief scientific and medical officer of ViiV Healthcare, also said, “This NDA, if approved, will provide a single-tablet, two-drug regimen option with DTG and 3TC that we believe could have an impact on the existing HIV treatment strategy and serve as a valuable option for people living with HIV.”
ViiV Healthcare is committed to challenging the status quo with innovations, based on our belief that no one should take more medicines than they need, Pottage added.
The company also submitted a priority review voucher to the FDA along with its NDA. Under the Prescription Drug User Fee Act, the anticipated target action date for an NDA with a priority review voucher is six months after the FDA issues a receipt.
ViiV Healthcare submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) in September, the company said.