Gilead’s Veklury becomes first treatment approved for COVID-19

The Food and Drug Administration has approved the first treatment for COVID-19. The agency has approved Gilead Sciences’ antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older to treat COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care, the agency said. 

This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization originally issued on May 1. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug's use for treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.

"The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency," said FDA commissioner Stephen Hahn. "Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA's Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks."