J&J seeks expanded pediatric indication for darunavir/cobicistat to treat HIV-1

J&J seeks expanded pediatric indication for darunavir/cobicistat to treat HIV-1 | Image Credit: © jarun011 - © jarun011 - stock.adobe.com.

Johnson & Johnson has recently submitted a supplemental New Drug Application (sNDA) to the FDA for an expanded indication of darunavir/cobicistat (Prezcobix) to include the treatment of HIV-1 infection in children at least 6 years of age who weigh at least 25 kg.¹

To aid administration for younger children, Johnson & Johnson has developed a new co-formulated tablet containing a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg).¹

"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, MD. Heaton is head of the Global Therapeutic Area for Infectious Diseases, Vaccines, and Global Public Health R&D at Johnson and Johnson.¹

The 2-drug, fixed-dose combination tablet contains 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.¹

"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,” Heaton said in a press release.¹

Data supporting the sNDA to the FDA is from a clinical study (NCT04718805) that evaluated the pharmacokinetics of the new combination tablet and established that it "is bioequivalent to darunavir and cobicistat when dosed as single agents," according to Johnson & Johnson. The phase 1 trial included 22 participants aged 18 to 55 years.^1,2

Safety, efficacy, and tolerability was established in a phase 2/3 clinical trial (NCT02016924) featuring and estimated enrollment of 130 participants aged 4 weeks to 17 years.^1,3

Key inclusion criteria included³:

• HIV-1 infected, virologically suppressed males and females age ≥ 4 weeks to < 18 years (according to requirements of enrolling Cohort).
• Body weight at screening ≥ 25 to < 40 kg (Cohort 2); ≥ 14 to < 25 kg (Cohort 3); ≥ 3 to < 25 kg (Cohort 4); ≥ 3 to < 14 kg (Cohort 5).
• Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening visit.

Johnson & Johnson stated based on these data, Janssen Products LP (division of J&J) is seeking the expanded approval to allow the use of darunavir/cobicistat in treatment-naïve and treatment-experienced pediatric patients aged 6 years and older who weight at least 25 kg and who have no viral resistance mutations associated with darunavir.¹

Currently, the product is indicated to treat HIV-1 infection in "treatment-naïve and treatment-experienced adults and adolescent patients weighing at least 40 kg with no darunavir resistance-associated mutations."¹

References:

1. Johnson & Johnson submits supplemental new Drug Application to US FDA seeking expanded pediatric indication for HIV-1 therapy Prezcobix. Johnson & Johnson. Press release. June 4, 2024. Accessed June 7, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-supplemental-new-drug-application-to-u-s-fda-seeking-expanded-pediatric-indication-for-hiv-1-therapy-prezcobix

2. A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions. ClinicalTrials.gov. Updated July 19, 2022. Accessed June 7, 2024. https://clinicaltrials.gov/study/NCT04718805

3. Study of Cobicistat-Boosted Atazanavir (ATV/​co), Cobicistat-Boosted Darunavir (DRV/​co) and Emtricitabine/​Tenofovir Alafenamide (F/​TAF) in Children With HIV. ClinicalTrials.gov. Updated June 7, 2024. Accessed June 7, 2024. https://clinicaltrials.gov/study/NCT02016924