The FDA on Tuesday announced that it approved ViiV Healthcare's filing for the fixed-dose oral therapy combining its integrase inhibitor Tivicay (dolutegravir) and Johnson & Johnson's non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine). Approval of the drug, which will be marketed under the name Juluca, makes it the "first complete treatment regimen containing only two drugs to treat certain adults with HIV-1, instead of three or more drugs included in standard HIV treatment," the agency said.
Specifically, Juluca is indicated for adults with HIV-1 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.
The FDA's decision was based on data from two late-stage trials involving 1024 patients whose virus was suppressed by their current anti-HIV treatment. Participants were randomly assigned to either continue with anti-HIV drugs or to switch to Juluca. Results unveiled last December found that the two-drug combination was non-inferior to three- or four-drug antiretroviral regimens at week 48.
Debra Birnkrant, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research, remarked that "limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients."
ViiV, which is majority-owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, entered a deal with Johnson & Johnson in 2014 to investigate the potential of combining Tivicay and Edurant in a single tablet. A priority review voucher, which GlaxoSmithKline had purchased for $130 million, was submitted to the FDA along with the marketing application for Juluca.
Meanwhile, Gilead Sciences announced in August that its submission of the fixed-dose combination of Descovy (emtricitabine/tenofovir alafenamide) plus the investigational integrase strand transfer inhibitor bictegravir was granted priority review by the FDA for the treatment of HIV-1 infection, with a decision anticipated in February 2018. Gilead's application seeking approval of the therapy has also been validated by regulators in Europe.
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