This article was written by Alessandra Nardone, Penta Foundation’s Senior Clinical Project Manager. It is taken from the Penta 2024 Annual Social Report.
When I was assigned as a Clinical Project Manager in the UNIVERSAL project in 2021, I knew we were working on something important, even though I could not have envisioned such an impact at that time. The objective was clear: to develop two child-friendly, fixed-dose combinations (FDC) for HIV treatment, one of which was Darunavir/Ritonavir (DRV/r). This was a priority identified by the WHO’s Global Accelerator for Paediatric Formulation (GAP-f) in 2019, through a panel of HIV experts (PADO).
In February 2024, a crucial moment arrived: we submitted the UNIVERSAL DRV/r pharmacokinetic modelling and simulation analysis to the US FDA. This submission represented a significant step, providing data to support the FDA’s decision on the new DRV/r FDC registration.
For me, this was more than a professional milestone. It was a privilege. As a Penta employee, I coordinated the collaborative work between our network experts from PHPT, Assistance publique – Hôpitaux de Paris (AP-HP), and CHAI, and presented the application to the FDA. It was the first time for Penta to lead on an FDA submission.
In March 2025, the FDA approved our modelling. This approval was a landmark step towards making the new DRV/r FDC available. This fixed-dose combination could revolutionise the approach to paediatric HIV treatment offering smoother dosing regimens, potential improvement in adherence and minimised number of pills children with HIV need to take.
My participation in the UNIVERSAL project gave me the true sense of collaborative efforts for advancing paediatric HIV treatments. It reinforces Penta’s commitment to developing better treatments for children globally.