J&J seeks broader approvals for pediatric HIV-1 therapy

Johnson & Johnson (J&J) has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA), aiming for expanded approval of its HIV-1 treatment, PREZCOBIX (darunavir/cobicistat), for children aged six years and older. The company is seeking approval for use in pediatric patients weighing at least 25kg. In Europe, similar applications have been submitted to the European Medicines Agency (EMA) for the medication, marketed under the name REZOLSTA.

If approved, PREZCOBIX/REZOLSTA will be available for both adults and children starting from the age of six. A new pediatric formulation has been developed, offering a lower dose tablet (darunavir 675mg/cobicistat 150mg) that is easier for children to swallow. The applications are backed by data from a clinical study sponsored by Janssen Research & Development, which showed that the new combination tablet is bioequivalent to the individual doses of darunavir and cobicistat.

Gilead Sciences conducted a Phase II/III clinical trial that demonstrated the efficacy, safety, and tolerability of cobicistat-boosted darunavir in treating younger children with HIV-1. PREZCOBIX/REZOLSTA combines darunavir, an HIV-1 protease inhibitor, with cobicistat, a CYP3A inhibitor that enhances the drug’s pharmacokinetics, allowing for once-daily dosing. Currently, the therapy is approved for use in adults and adolescents weighing at least 40kg who do not have resistance mutations to darunavir. Darunavir is marketed as PREZISTA in the US by Janssen Products, while cobicistat, developed by Gilead Sciences, is sold as TYBOST.

The fixed-dose combination of PREZCOBIX/REZOLSTA is a collaborative effort between Janssen R&D Ireland and Gilead. Penny Heaton, head of global therapeutic areas for infectious diseases and vaccines at Johnson & Johnson’s global public health R&D, emphasized the importance of this development in providing new treatment options for young people living with HIV. She noted that if approved, the medicine would offer healthcare providers a new treatment regimen that ensures weight-appropriate dosing, better meeting the needs of younger patients.

This latest development reflects J&J’s continuous efforts to extend treatment options for young HIV patients. The company recently acquired global rights to Numab Therapeutics’ investigational antibody, NM26, for atopic dermatitis, indicating an ongoing commitment to broaden its portfolio in treating various health conditions.