Veklury Becomes the First FDA-Approved COVID-19 Treatment for Children Under 12

Gilead’s Veklury (remdesivir) gets FDA approval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12.

The world is in the hold of the COVID-19 pandemic for more than two years now. SARS-CoV-2 is known to affect people of all ages. In the US, the vaccination for the virus is currently provided to individuals five years of age and older. Veklury (remdesivir) comes into focus while there is search for COVID-19 treatment for infants.

Why Veklury?                  

Veklury is an adenosine nucleotide prodrug designed by Gilead Sciences Inc. It is a promising drug that has so far been engaged in the treatment against seven families of viruses that are the filo-, paramyxo-, pneumo-, bunya-, arena-, rhabdo- and flaviviruses. As an urgent situation stirred due to the pandemic, along with Veklury drugs such as ribavirin, penciclovir, favipiravir, nafamostat, nitazoxanide and chloroquine were evaluated in vitro for their antiviral efficiency against a clinical isolate of the novel coronavirus. The in vitro studies showed that remdesivir was effective among the drugs because it had the strongest antiviral activity as it could block virus infection at low micromolar concentrations with minimal cell toxicity.

Veklury as a COVID-19 Drug for Infants 

The US Food and Drug Administration (FDA) has approved the administration of Veklury for pediatric patients who are 28 days of age and older and weigh at least three kilograms (about seven pounds). This is the only approved COVID-19 treatment for children under 12 years of age. The drug is approved for children hospitalized with COVID-19 or non-hospitalized children who fall under the high-risk category for developing severe COVID-19.

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need,” said Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, in the FDA’s press release.

The FDA highlighted that Veklury is not a substitute for vaccination in people eligible for COVID-19 vaccination and booster doses.

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Clinical Trial on Pediatric Patients

The FDA’s approval of Veklury for pediatric patients was given after results from the CARAVAN Phase II/III single arm, open-label clinical trial. The trial enrolled 53 pediatric patients (at least 28 days old and weighing at least three kilograms) with mild to severe COVID-19. The patients received Veklury for up to 10 days. The study showed that at day 10 and last assessment, 75% and 85% of patients, respectively, showed clinical improvement. About 60% of them were discharged by day 10, while 83% were discharged by day 30. The pharmacokinetic and safety results of Veklury in pediatric patients was found to be like that in adult patients.

“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, Atrium Health-Levine Children’s Hospital in Charlotte, North Carolina, in Gilead’s press release.

Possible Side Effects of Veklury

Veklury is approved to be administered in the form of injection only. Though many studies have proved its positive side of efficiency in the treatment of COVID-19 infected patients, the drug also has side effects including increased levels of liver enzymes which might indicate liver damage. Other side effects include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, sweating or shivering, among others.