CHMP recommended that the European Commission approve the antiretroviral drug Juluca
The Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve the combined dolutegravir/rilpivirin (brand name: Juluca) ARV-drug with a fixed dosage (50 mg and 25 mg, respectively) for once-daily administration, Reuters reports.
The recommendation of CHMP is one of the key factors influencing the decision of the European Commission. The regulator's response is expected by the end of the second quarter of 2018, GSK said in a statement. Juluca was already approved by the FDA (USA) in November 2017.
Juluca is two drug HIV regimen and should replace the current three-components antiretroviral regimen. The replacement might be possible for persons who have undetectable virus load for more than 6 months with no history of treatment failure.