The fixed-dose combination of PREZCOBIX/REZOLSTA is a collaborative effort between Janssen R&D Ireland and Gilead. Credit: Dmytro Zinkevych/ Shutterstock.
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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.
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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.
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.
Johnson & Johnsoninfectious 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.”