The US Food and Drug Administration (FDA) has granted approval to ViiV Healthcare, a specialist HIV healthcare company, for its two-drug regimen (2DR), Juluca, intended to treat certain adults with human immunodeficiency virus type 1, it was reported yesterday.
The product is said to be the first 2DR, which includes dolutegravir 50mg produced by ViiV Healthcare and rilpivirine 25mg produced by Janssen Therapeutics. It 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 regimen for around six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of the product.
The approval was based on data from two pivotal phase III clinical trials, known as Sword-1 and Sword-2.
GSK reports positive Phase III data for low-carbon version of Ventolin inhaler
Terns Pharmaceuticals reports topline 12-week data from Phase 2 trial of TERN-601 in obesity
The Los Angeles Trust for Children's Health Appoints Dr Sarah Rodman as New Executive Director
Cumberland Pharmaceuticals adds FDA-approved oral capsule for H. pylori to commercial portfolio
Genentech's Gazyva (obinutuzumab) receives US FDA approval to treat adults with lupus nephritis
ACG to invest USD200m in US hard-shell capsule manufacturing
Charles River and X-Chem form strategic collaboration to accelerate hit identification
Merck reports long-term survival benefits of Keytruda in non-small cell lung cancer
Avacta reports promising Phase 1a data for faridoxorubicin at ESMO 2025