The supplemental new drug application is expanded to include the youngest COVID-19 patients.
The Food and Drug Administration (FDA) has expanded the supplemental new drug application of remdesivir to include pediatric patients who are older than 28 days, weigh at least 3 kg, who are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19. With this expanded indication, the youngest patients will be eligible for the only approved treatment for patients under 12.
“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, said in a statement. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”
Under the expanded indication, a 3-day remdesivir treatment is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for COVID-19 disease progression. For those hospitalized pediatric patients who do not require invasive mechanical ventilation and/or extracorporeal membrane oxygenation, a 5-day treatment course is recommended.
This approval was supported by results from the CARAVAN phase 2/3 single arm, open-label study, which demonstrated that remdesivir 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 remdesivir.
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.
This approval follows the sNDA approval for remdesivir back in January for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19.