The FDA announces the approval of a new two-drug combo option for those living with HIV and undetectable for 6 months without resistance by ViiV Healthcare and Janssen.
Look at the Food and Drug Administration (FDA) being the show off kid in our government—still working this close to the Thanksgiving holiday break, and giving a nice pre-holiday gift to two relevant pharmaceutical companies by approving a new HIV drug for those living with the virus in the U.S..
The new drug is called: Juluca. This newly approved drug is the work of two otherwise competing pharmaceutical companies that have each combined a drug from their own arsenals to make a unique two-drug combo for those living with HIV—the powerhouse Janssen Pharmaceuticals and ViiV Healthcare.
Here’s how the drug is being touted:
JULUCA® is a once-daily, antiretroviral combination of dolutegravir, an integrase strand transfer inhibitor (INSTI) marketed by ViiV Healthcare as TIVICAY®, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Janssen as EDURANT®. With JULUCA®, people living with HIV who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months and have no prior history of treatment failure – and no known resistance to the individual components of JULUCA® – now have a new treatment option to consider.
In a late afternoon (released per pharmaceutical protocols for joint company drugs with the submitting party to the FDA getting first dibs to the media) subsequent press release from Janssen’s team characterizes the new drug this way: “Provides New Treatment Option for Stable, Virologically Suppressed Adults Living with HIV-1.”
So let’s celebrate this! A new 2 drug only combo is great news and proof how far we have come since the beginning of the epidemic.
Here’s the FDA press release:
FDA approves first two-drug regimen for certain patients with HIV
SILVER SPRING, Md., Nov. 21, 2017
The U.S. 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. 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.
“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
HIV weakens a person’s immune system by destroying important cells that fight disease and infection. According to the Centers for Disease Control and Prevention, an estimated 1.1 million people in the United States are living with HIV, and the disease remains a significant cause of death for certain populations.
Juluca’s safety and efficacy in adults were evaluated in two clinical trials of 1,024 participants whose virus was suppressed on their current anti-HIV drugs. Participants were randomly assigned to continue their current anti-HIV drugs or to switch to Juluca. Results showed Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs.
The most common side effects in patients taking Juluca were diarrhea and headache. Serious side effects include skin rash and allergic reactions, liver problems and depression or mood changes. Juluca should not be given with other anti-HIV drugs and may have drug interactions with other commonly used medications.
The FDA granted approval of Juluca to ViiV Healthcare, though it is the result of the work of also Janssen.
Congrats to Janssen and ViiV Healthcare, and watch for more news about this new, two-drug HIV combo option later this year.
Updated: 7:29pm – This article was updated after more information became available that reveals this drug is a joint product from Janssen Pharmaceuticals and ViiV Healthcare.