Juluca is said to be the first 2DR, which includes dolutegravir 50mg produced by ViiV Healthcare and rilpivirine 25mg produced by Janssen Therapeutics.
Dolutegravir 50mg is an integrase strand transfer inhibitor, while rilpivirine 25mg is a non-nucleoside reverse transcriptase inhibitor.
Juluca has been approved as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
ViiV Healthcare CEO Deborah Waterhouse said: “The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care.
“This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”
The approval was based on data from two pivotal phase III clinical trials, including Sword-1 and Sword-2.
According to the company, the trials demonstrated that the two-drug regimen achieved non-inferior viral suppression at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the Sword-1 and Sword-2 studies.
ViiV Healthcare CEO Deborah Waterhouse said: “The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care.
“This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”