Laurus Labs has submitted an application to the US Food and Drug Administration (FDA) for the tentative approval of paediatric Darunavir/ritonavir (pDRV/r (120/20 mg)). UNIVERSAL is the first product development project from the World Health Organisation’s (WHO) GAP-F project which was established to promote the development of safer, more effective and more durable paediatric formulations made available for children at a faster rate. Data produced through UNIVERSAL’s modelling and simulation data, submitted to the FDA earlier this year by Penta, CHAI, PHPT and AP-HP, will support their decision on the drug’s registration. This is promising news for children with HIV who are taking dolutegravir (DTG) but finding that is not working.

DRV is a protease inhibitor, a medication that combats HIV by blocking the enzyme it needs to replicate. When combined with ritonavir, DRV effectively reduces the amount of HIV in the body, leading to increased CD4 cells, the essential immune cells targeted by HIV. By bolstering the immune system and lowering the viral load, DRV/r significantly decreases the risk of HIV-related illnesses and death.

The development of paediatric DRV/r (120/20 mg) is significant as there is a need for more effective and accessible treatments for children with HIV. According to a recent report by the World Health Organisation, observational studies have found alarmingly high levels of HIV resistance to dolutegravir, one of the most widely used antiretrovirals. With this growing concern, safe and effective alternatives for children with HIV are much needed.

It is important to note that this is still early stages in the approval process and though more research is needed to confirm the drug’s efficacy and safety, this application is a positive step forward in the fight against HIV in children.