Johnson & Johnson (J&J) has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking expanded approval for the use of its HIV-1 therapy, PREZCOBIX (darunavir/cobicistat), in children aged six years and above.
Approval is being sought for PREZCOBIX use in paediatric patients weighing a minimum of 25kg.
In Europe, the company has submitted applications to the European Medicines Agency for the paediatric use of the medication, marketed as REZOLSTA.
Approval of the applications would enable PREZCOBIX/REZOLSTA to be administered to both adults and paediatric patients from the age of six years.
A new paediatric formulation has been developed, featuring a lower dose tablet (darunavir 675mg/cobicistat 150mg) making it easier for children to swallow.
The applications are supported by data from a clinical study, sponsored by Janssen Research & Development (R&D), which indicated that the new combination tablet is bioequivalent to the individual doses of darunavir and cobicistat.
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By GlobalData
A Phase II/III clinical trial by Gilead Sciences has established 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 pharmacokinetics of the therapy, allowing for once-a-day dosing.
The therapy is currently approved for use in adults and adolescents weighing a minimum of 40kg without resistance mutations to darunavir.
Darunavir is marketed by Janssen Products as PREZISTA in the US, and 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.
Johnson & Johnson infectious diseases and vaccines and global public health R&D global therapeutic area head Penny Heaton stated: “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.
“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.”
The latest development comes after Johnson & Johnson gained the global rights to Numab Therapeutics’ investigational first-in-class antibody, NM26 for atopic dermatitis.
