FDA approves first treatment for young children with COVID-19

The FDA has approved Veklury for pediatric patients aged 28 days and older who are hospitalized for COVID-19 or have mild to moderate COVID-19 and are at risk for severe disease.

It is the first COVID-19 treatment approved in the U.S. for young children, according to the FDA.

“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,” Patrizia Cavazzoni, MD, the director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “[The] approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”

In October 2020, Veklury (remdesivir, Gilead Sciences) was approved for adults and children aged older than 12 years who are hospitalized for COVID-19.

The expansion of the drug’s approval was supported by data from the CARAVAN phase 2/3 single arm, open-label clinical trial, which includes 53 pediatric patients.

Overall, 75% of patients showed clinical improvement at day 10 and 85% at the last assessment, according to Gilead Sciences. Also, 60% of patients were discharged from the hospital by day 10 and 83% were discharged by day 30. However, 72% of patients experienced adverse events and 21% experienced serious adverse events. The safety and pharmacokinetic results from the pediatric phase were similar to those in adults, according to the FDA.

The FDA approved remdesivir as a 3-day treatment regimen administered via injection to children weighing at least 3 kg.

“This approval means that remdesivir can potentially provide meaningful clinical improvement, by reducing disease progression and helping children recover from COVID-19 more quickly,” Amina Ahmed, MD, the chief medical director of pediatric infectious diseases and a professor of infectious diseases at Atrium Health-Levine Children’s Hospital in North Carolina, said in a Gilead Sciences press release. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”

References:

Coronavirus (COVID-19) update: FDA approves first COVID-19 treatment for young children. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-approves-first-covid-19-treatment-young-children. Published April 25, 2022. Accessed April 26, 2022.

Veklury (remdesivir) is first and only approved treatment for pediatric patients under 12 years of age with COVID-19. https://investors.gilead.com/news-releases/news-release-details/vekluryr-remdesivir-first-and-only-approved-treatment-pediatric. Published April 25, 2022. Accessed April 26, 2022.