Johnson & Johnson’s paediatric HIV-1 treatment secures FDA approval
20 Mar 2024
Drug ApprovalAcquisitionImmunotherapyVaccineClinical Study
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Source: Pharmaceutical Technology
EDURANT PED was shown to suppress HIV-1 when used alongside other ARVs. Credit: josefkubes via Shutterstock.
Johnson & Johnson has received approval from the US Food and Drug Administration (FDA) approval for EDURANT PED to treat human immunodeficiency virus-1 (HIV-1) in children.
The treatment is indicated for use along with other antiretroviral therapies (ARVs), expanding therapy options for paediatric patients who are treatment-naive and have an HIV-1 RNA viral load of less than 100,000 copies per mililitre.
Patients must also be at least two years old and weigh a minimum of 14kg and less than 25kg.
The approval for the drug has been granted based on data from the PAINT and PICTURE studies in paediatric patients.
According to the findings, EDURANT PED was demonstrated to suppress the virus when used alongside other ARVs in treatment-naive paediatric subjects.
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Marketed under the names EDURANT and EDURANT PED, rilpivirine is a nonnucleoside reverse transcriptase inhibitor designed specifically for the treatment of HIV-1.
Johnson & Johnson infectious diseases and vaccines global therapeutic area head Penny Heaton said: “Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their treatment journey.
“While the population of young children living with HIV is small, additional treatment options remain key to ensuring that each person living with HIV can be matched to a treatment regimen that is right for them.”
The latest development comes after Johnson & Johnson concluded the acquisition of clinical-stage biopharmaceutical company Ambrx Biopharma in a deal totalling $2bn.
The companies entered a definitive agreement to execute the deal in January 2024.
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