The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking to expand the indication of Edurant (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded paediatric use in Europe. These applications reflect Janssen’s longstanding commitment to address the needs of adults, adolescents and children affected by the global HIV epidemic.
If the new applications are approved, Edurant, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger paediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children.
“We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., global therapeutic area head, infectious diseases and vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”
The expanded paediatric applications are supported by data from the phase 2 PAINT (NCT00799864) and PICTURE (NCT04012931) studies, which showed that Edurant, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive paediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.
The expansion of the Edurant indication would mark the latest step forward in Janssen’s efforts to make its HIV medicines available to young people living with HIV. In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.
In addition to driving innovation in HIV care, Johnson & Johnson also works with vulnerable communities on the global frontlines of the HIV epidemic, and has supported collaborative initiatives like Positively Fearless, the DREAMS Partnership and the MenStar Coalition. We also support the New Horizons Collaborative, which is working to address the unmet needs of HIV treatment-experienced children, adolescents and young adults in sub-Saharan Africa.
Edurant is a human immunodeficiency virus type 1 (HIV-1) specific, nonnucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.
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