Johnson & Johnson Submits Supplemental New Drug Application to Expand Indication of Prezcobix for HIV-1 in Children at Least 6 Years Old

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Johnson & Johnson (J&J) announced that it has submitted a supplemental New Drug Application (NDA) to the FDA to expand the use of Prezcobix (darunavir/cobicistat) to treat HIV-1 infection in children as young as 6 years of age and weighing a minimum of 55 lbs. A similar application for extension was also filed with the EMA.

Submission to both agencies was based on promising data from a clinical study that evaluated the pharmacokinetics of a new formulation of the tablet, with a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg). The trial found that the new formulation was equivalent to darunavir and cobicistat when dosed as single agents (NCT04718805).¹

“We are proud of this latest step in our years of work to ensure that some of the youngest people living with HIV have access to different treatment regimens that can work for them,” said Penny Heaton, MD, global therapeutic area head, infectious diseases and vaccines, global public health R&D, J&J, in the press release. “If approved, this medicine could offer healthcare providers a new treatment option that ensures weight-appropriate dosing to better meet the needs of young people living with HIV.”

Previously, the safety, efficacy, and tolerability of Prezcobix for use by younger children was determined during a Phase II/III clinical trial conducted by Gilead Sciences (NCT02016924). Currently, Prezcobix is approved for use in both adults and adolescents weighing a minimum of 88 lbs. It combines darunavir, which is an HIV-1 inhibitor, with cobicistat, a CYP3A inhibitor aiming to enhance pharmacokinetics of the therapy, enabling once-daily dosing as a result.^1,2

J&J cautions that use of Prezcobix has the potential to cause liver issues, which in some cases may be life threatening. Additionally, it may cause skin rashes, fever, tiredness, muscle or joint pain, and red or inflamed eyes.¹

According to the Centers for Disease Control and Prevention (CDC), there were 53 children under 13 years of age diagnosed with HIV in 2021, with an additional six coming from US dependencies. From 2017 to 2020, around 12,569 children were born with exposure to HIV, but never acquired it perinatally. In most cases, HIV passes to children as a result of transition from the birthing parent during pregnancy, childbirth, or breastfeeding. However, implementing HIV medicines has supported the reduction of transmission rates to 1% or less in the United States and Europe.

While there are currently ways to treat children with HIV, there are several factors involved with it. Depending on the rate at which a child grows, dosage levels may be different. Adherence can be a challenge due to multiple factors, such as age and developmental stages, adverse effects of the medication, and financial issues.³

References

1. Johnson & Johnson Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy PREZCOBIX®. Johnson & Johnson. June 4, 2024. Accessed June 5, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-supplemental-new-drug-application-to-u-s-fda-seeking-expanded-pediatric-indication-for-hiv-1-therapy-prezcobix

2. HIV and Children. HIV Info. February 5, 2024. Accessed June 5, 2024. https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-and-children#:~:text=According%20to%20the%20Centers%20for,this%20age%20group%20in%202017.

3. J&J seeks expanded approvals for paediatric HIV-1 therapy. Pharmaceutical Technology. June 5, 2024. Accessed June 5, 2024. https://www.pharmaceutical-technology.com/news/johnson-johnson-approvals-hiv-1/?cf-view