Juluca FDA approval : ViiV Healthcare’s 2-drug regimen Juluca has secured approval from the US Food and Drug Administration (FDA) for the maintenance treatment of virologically suppressed human immunodeficiency virus type 1 (HIV-1) infection.
The HIV drug regimen Juluca, which is intended to be taken as a single pill daily once, is a combination of ViiV Healthcare’s integrase strand transfer inhibitor dolutegravir 50mg and Janssen Therapeutics’ non-nucleoside reverse transcriptase inhibitor rilpivirine 25mg.
Juluca FDA approval is for adults, who have HIV-1 RNA less than 50 copies per mL on a stable antiretroviral (ART) regimen for a minimum of six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of the HIV drug regimen.
ViiV Healthcare is a joint venture between GlaxoSmithKline (GSK) Pfizer and Shionogi.
Commenting on Juluca FDA approval, John Pottage, chief scientific and medical officer of ViiV Healthcare said: “Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive 2-drug regimen research and development programme built around the characteristics of dolutegravir.
“Juluca, our new 2-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.”
Juluca FDA approval comes on the basis of data from two phase 3 trials SWORD-12 and SWORD-2 featuring 1,024 participants which showed the 2-drug regimen registerering non-inferior viral suppression at 48 weeks.
The HIV drug regimen was compared against a three- or four-drug regimen in both pooled and individual analyses of the two trials.
Overall, results from the two trials demonstrated Juluca to be effective in suppressing the virus. Virologic suppression rates were identical between the treatment arms of the trials.
FDA Center for Drug Evaluation and Research, Division of Antiviral Products director Debra Birnkrant on the Juluca FDA approval said: “Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients.”