The US federal agency has approved the antiviral drug Veklury (remdesivir), produced by Gilead, for dosing hospitalized patients 12 years and over diagnosed the virus.
With its approval of Gilead’s veklury, the US Food and Drug Administration (FDA) has issued its first approval for a drug intended to treat COVID-19. The treatment is intended to be administered in a hospital or acute-care facility, and only to patients weighing 88 lbs (40kg) or more.
The agency points out the approval does not cover patients authorized to receive Veklury under an emergency use authorization issued in May. That EUA involved suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing between about 7.7 lbs (3.5 kg) to 88 lbs (40 kg).
FDA commissioner Stephen Hahn commented that the agency is “committed” to helping to expedite the development and distribution of COVID-19 treatments.
“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,” Hahn said. “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.”
The approval of Veklury reported supported by FDA’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. One trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated, reportedly showing a shorter recovery time compared to the placebo group.
Another multi-center trial of hospitalized adults with moderate COVID-19 involved giving them Veklury for either 5 or 10 days with standard of care. Researchers reported the 10-day subjects showed greater improvement than the 5-day group.
Another trial of hospitalized adult patients with severe COVID-19 also issued Veklury for either 5 or 10 days. Results of this trial reportedly showed similar odds of improvement among both groups, with no statistically significant variances in recovery or mortality rates between the two.
The FDA had granted the Veklury application Fast Track and Priority Review designations. It also granted it a Material Threat Medical Countermeasure Priority Review Voucher, intended to provide additional incentives for certain medical products that may treat or prevent harm from specific chemical, biological, radiological and nuclear threats.
In mid-October, the World Health Organization (WHO) announced the results of its Solidarity Therapeutics Trial, examining the effectiveness of remdesivir and other therapies in treating COVID-19 patients. After 6 months, the agency reported that trial results showed the drug had little to no effect in lessening the severity or shortening the duration of symptoms.
The agency could not be reached for comment.