Johnson&Johnson Seeks FDA and EMA Approval for Expanded Pediatric Use of HIV Drug

Submission of Supplemental New Drug Application

Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The application aims 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®.

Potential New Pediatric Indication

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.

Statement from Johnson & Johnson

Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines and Global Public Health R&D at Johnson & Johnson, commented, "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."

Supporting Clinical Data

The applications to the FDA and EMA are supported by data from a clinical study sponsored by Janssen Research & Development, LLC, which evaluated the pharmacokinetics of the new combination tablet and established its bioequivalence 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 were established in a Phase 2/3 clinical trial conducted by Gilead Sciences (NCT02016924).

Expanded Indication Sought

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. These filings reflect Johnson & Johnson’s commitment to expanding access to its treatment portfolio to support people of all ages living with HIV.

About PREZCOBIX®/REZOLSTA®

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 pharmacokinetic (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.

Highlights

- Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the FDA and a parallel application to the EMA for the expanded pediatric use of PREZCOBIX®/REZOLSTA®.

- If approved, the drug could be used to treat HIV-1 in children as young as 6 years old, weighing at least 25 kg.

- A new pediatric dose tablet has been developed for easier administration.

- The applications are supported by clinical data demonstrating bioequivalence and safety.

- This expansion reflects Johnson & Johnson's ongoing commitment to providing treatment options for people of all ages living with HIV.