The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Gilead Sciences’ Veklury (remdesivir) for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death.
This approval follows the recent sNDA approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19.
Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for COVID-19 disease progression.
For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a 5-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,” said Amina Ahmed, MD, Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina in the United States. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”
This approval was supported by results from the CARAVAN Phase 2/3 single arm, open-label study, which demonstrated that Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19 with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults.
Of the 53 pediatric patients enrolled in the CARAVAN study, no new safety signals were apparent for patients treated with Veklury. Overall, 75% and 85% showed clinical improvement (≥2 point increase on the ordinal scale) at Day 10 and last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively.
In the study 38 patients (72%) experienced adverse events (AEs), with 11 patients (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 study entry or with COVID-19 disease during hospitalization. These data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022).
“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, MD, PhD, Chief Medical Officer, Gilead Sciences. “Effective and tolerable options for children require our best science and a dedicated focus. With the recent opening of our Gilead Pediatric Center of Excellence in Dublin, which is responsible for coordinating pediatric clinical trials for treatments for HIV, hepatitis B and COVID-19, we will continue our research to help address unmet treatment needs for children.”
In the United States, Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (28 days and older and weighing at least 3 kg) who are either hospitalized or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is contraindicated in patients who are allergic to Veklury or any of its components.