FDA approves remdesivir for treatment of COVID-19

The US Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for use in adult and paediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalisation.

The marketing authorisation has been granted to Gilead Sciences. The company says that remdesivir should only be administered in a hospital or a healthcare setting capable of providing acute care comparable to inpatient hospital care. 

The FDA says that this approval does not include the entire population that had been authorised to use remdesivir under an Emergency Use Authorization (EUA). 

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Dr 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.”

The approval of remdesivir was supported by the agency’s analysis of data from three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe COVID-19.

One trial was a randomised, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the US 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. The trial looked at 1,062 hospitalised subjects with mild, moderate and severe COVID-19 who received remdesivir or placebo, plus standard of care. 

The second trial was a randomised, open-label multi-centre clinical trial of hospitalised adult subjects with moderate COVID-19. It compared treatment with remdesivir for five days and treatment with remdesivir for 10 days with standard of care. 

A third separate, randomised, open-label multi-centre clinical trial of hospitalised adult subjects with severe COVID-19 compared treatment with remdesivir for five days and treatment with remdesivir for 10 days.