FDA approves first two-drug regimen for certain patients with HIV

The US Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment and aimed at lessening the side effect burden of current treatments that combine three or four medicines.

The FDA granted approval of Juluca to ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline (LSE: GSK), with Pfizer (NYSE: PFE) and Shionogi (TY: 4507) as shareholder.

Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat adults with HIV-1 infections whose virus is currently suppressed on a stable 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.