Janssen seeks USFDA nod for expanded pediatric indication for HIV-1 therapy Edurant
Titusville: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. 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...
Titusville: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. 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 pediatric use in Europe.
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 pediatric 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 pediatric applications are supported by data from the Phase 2 PAINT and PICTURE studies, which showed that EDURANT, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric 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.
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.
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