JnJ submits application to USFDA for expansion of Pediatric indication for HIV-1 Therapy Prezcobix
Titusville: Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of PREZCOBIX (darunavir/cobicistat) to include the treatment of HIV-1 infection in younger children at least 6 years of age weighing at least 25 kg.
A parallel line extension application and type 2 variation application have also been submitted to the European Medicines Agency (EMA) for expanded pediatric use in Europe, where the product is marketed as REZOLSTA.
If the applications are approved, PREZCOBIX/REZOLSTA could be administered to adults and pediatric patients at least 6 years of age, weighing at least 25kg. A new co-formulated tablet containing a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg) has been developed to aid administration for younger children. The new pediatric tablets are scored to facilitate breaking for ease of swallowing.
“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, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines and Global Public Health R&D at Johnson & Johnson. “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 applications to the FDA and EMA are supported by data from a clinical study sponsored by Janssen Research & Development, LLC, that evaluated the pharmacokinetics of the new combination tablet and established that it is bioequivalent to darunavir and cobicistat when dosed as single agents (NCT04718805). The efficacy, safety and tolerability of cobicistat-boosted darunavir for the treatment of younger children with HIV-1 was established in a Phase 2/3 clinical trial conducted by Gilead Sciences (NCT02016924).
Based on these data, Janssen Products, LP, a division of Johnson & Johnson, is seeking an expanded indication to allow the use of PREZCOBIX/REZOLSTA in treatment-naïve and treatment-experienced pediatric patients aged 6 years and older, weighing at least 25 kg, and who have no viral resistance mutations associated with darunavir.
PREZCOBIX/REZOLSTA is a two-drug fixed-dose combination tablet containing darunavir, an HIV-1 protease inhibitor, and cobicistat, a CYP3A inhibitor that serves as a PK enhancer or “booster.” The booster enables once-daily dosing and optimal therapeutic levels of darunavir.
This product is currently indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults and adolescent patients weighing at least 40 kg with no darunavir resistance-associated mutations.
Darunavir as a single agent is marketed by Janssen Products, LP as PREZISTA in the United States, and cobicistat, developed by Gilead Sciences, Inc., is marketed as TYBOST. The fixed-dose combination PREZCOBIX/REZOLSTA is a collaboration between Janssen R&D Ireland and Gilead Sciences, Inc.
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