Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application for Veklury.
The treatment – also known as remdesivir – is designed for patients who are older than 28 days, weighing at least 3kg and have either been hospitalised with COVID-19 or have the virus in a mild-to-moderate form.
A three-day treatment regimen is recommended to help prevent hospitalisation in non-COVID-19 patients who are at high risk of disease progression. For hospitalised patients who do not require invasive mechanical ventilation and/or ECMO, a five-day treatment course is recommended.
“This approval means that remdesivir can potentially provide meaningful clinical improvement, by reducing disease progression and helping children recover from COVID-19 more quickly,” explained Dr Amina Ahmed, paediatric infectious disease specialist at Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina.
She added: “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society – children.”
Veklury’s approval was supported by results from the CARAVAN phase 2/3, open-label studies, which demonstrated that the therapy was well-tolerated among paediatric patients hospitalised with the coronavirus.
It demonstrated that the condition of a high proportion of the 53 participants improved after the treatment, with 75% and 85% showed clinical improvement during the trials, while 60% and 83% were discharged by day 10 and day 30, respectively.
In the study, 72% of patients experienced adverse events, with 21% experiencing serious adverse events (SAEs) that were determined not to be study-drug related, including three participant deaths, which were consistent with the patients’ underlying medical conditions prior to the study entry.
“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,” said Merdad Parsey, chief medical officer at Gilead Sciences.
“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.”
Veklury is approved for temporary use in approximately 50 countries worldwide.