Veklury is indicated for patients who are admitted to the hospital or have a mild-to-moderate disease and are at increased disease progression risk, including hospitalisation or death
Gilead secures FDA approval for Veklury to treat Covid-19 in paediatric patients. Credit: (PIRO4D from Pixabay)
Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for Veklury (remdesivir) to treat Covid-19 in paediatric patients aged over 28 days.
Veklury is a nucleotide analogue of Gilead Sciences. It is a recommended therapy for reducing disease progression in non-hospitalised Covid-19 patients who are at increased risk.
It is indicated for patients who are admitted to the hospital or have the mild-to-moderate disease and are at increased disease progression risk, including hospitalisation or death.
The FDA approval follows the recent sNDA approval for Veklury to treat non-hospitalised adult and adolescent patients at increased risk of disease progression.
As part of the latest expanded indication, a three-day treatment course of Veklury is advised for paediatric patients in the non-hospital setting.
The FDA has recommended a five-day regimen for hospitalised patients who do not need invasive mechanical ventilation and/or ECMO.
The regulatory approval is based on the results from the open-label, single-arm Phase II/III CARAVAN clinical trial of Veklury.
The company stated that the CARAVAN study results reveal that Veklury was well-tolerated in hospitalised Covid-19 paediatric patients while an increased proportion of participants showed clinical improvement and recovery.
Gilead Sciences chief medical officer Merdad Parsey said: “The expanded indication for Veklury for the treatment of children is a testament to the safety, tolerability and efficacy profile of this therapy, which has remained the foundational antiviral for Covid-19 treatment.
“With the recent opening of our Gilead Pediatric Center of Excellence in Dublin, which is responsible for coordinating paediatric clinical trials for treatments for HIV, hepatitis B and Covid-19, we will continue our research to help address unmet treatment needs for children.”