Policy & Regulation
The US Food and Drug Administration grants approval to ViiV Healthcare's Juluca
23 November 2017 -

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.