HIV-1 treatment expansion is the goal of Johnson & Johnson (J&J) as they have announced the submission of a supplemental New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), aiming to extend the use of Prezcobix (darunavir/cobicistat) for children as young as six years old and weighing a minimum of 55 pounds. A similar application has also been filed with the European Medicines Agency (EMA).
The submissions to both regulatory agencies are based on promising data from a clinical study that evaluated the pharmacokinetics of a new formulation of the tablet. This new formulation, with a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg), was found to be equivalent to darunavir and cobicistat when administered as single agents. The study, identified as NCT04718805, demonstrated that the new combination tablet effectively maintained therapeutic drug levels in children.
“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 at J&J. “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.”
Expanded Approval for Pediatric HIV-1 Treatment Offers New Hope for Younger Children
Prezcobix is currently approved for use in adults and adolescents weighing at least 88 pounds. It combines darunavir, an HIV-1 protease inhibitor, with cobicistat, a CYP3A inhibitor that enhances the pharmacokinetics of darunavir, allowing for once-daily dosing. The safety, efficacy, and tolerability of Prezcobix for use in younger children were previously established in a Phase II/III clinical trial conducted by Gilead Sciences (NCT02016924).
The approval of Prezcobix for younger children would provide healthcare providers with an important new option for treating pediatric HIV-1. By ensuring weight-appropriate dosing, the therapy could better meet the specific needs of younger patients. However, J&J cautions that Prezcobix use has the potential to cause liver issues, which in some cases may be life-threatening. Other side effects include skin rashes, fever, tiredness, muscle or joint pain, and red or inflamed eyes.
Johnson & Johnson Seeks FDA and EMA Approval to Expand Prezcobix for Pediatric HIV-1 Treatment
According to the Centers for Disease Control and Prevention (CDC), 53 children under the age of 13 were diagnosed with HIV in the United States in 2021, with an additional six cases from U.S. dependencies. Between 2017 and 2020, approximately 12,569 children were born with exposure to HIV but did not acquire the infection perinatally. Most pediatric HIV cases result from transmission from the birthing parent during pregnancy, childbirth, or breastfeeding. The implementation of HIV medicines has significantly reduced transmission rates to 1% or less in the United States and Europe.
Despite existing treatments for children with HIV, several factors complicate treatment. Dosage levels may need to be adjusted according to the child’s growth rate, and medication adherence can be challenging due to age, developmental stages, side effects, and financial issues.
Johnson & Johnson’s effort to expand the indication of Prezcobix for younger children represents a critical advancement in pediatric HIV-1 treatment. If approved by the FDA and EMA, this expanded use could significantly improve the management of HIV-1 in children, offering a new, effective, and age-appropriate therapeutic option. This initiative underscores the ongoing commitment to addressing the unique challenges faced by younger populations living with HIV and improving their overall health outcomes.
Resource: Johnson and Johsnon, June 05, 2024
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