FDA authorizes Gilead’s remdesivir for emergency use

Regulatory NewsRegulatory News
| 01 May 2020 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Friday issued an emergency use authorization (EUA) allowing the use of Gilead Sciences’ remdesivir to treat hospitalized patients with severe cases of coronavirus disease (COVID-19).
The EUA comes just two days after the National Institutes of Health (NIH) announced preliminary results from a randomized trial that found patients treated with remdesivir had a 31% shorter time to recovery than patients taking a placebo.
Results from other studies of remdesivir have been mixed. In a Chinese study published the same day in The Lancet, researchers were unable to identify a statistically significant clinical benefit, though that study was halted early due to recruitment issues. Another unpublished US study comparing 5- and 10-day dosing regimens found patients in both arms of the study had similar improvement in clinical status.
“Today's action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective," said FDA Commissioner Stephen Hahn.
FDA says it “determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19” after reviewing the available evidence, and that the potential benefits outweigh the risks in part because there are no adequate or approved treatments for the disease.
However, FDA notes that “there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19.”
This is the second EUA FDA has issued for therapeutics to treat COVID-19 after the agency issued one allowing the use of hydroxychloroquine and chloroquine in late March. (RELATED: FDA EUA Allows States to Receive Unapproved COVID-19 Treatments, Regulatory Focus 30 March 2020).
Distribution of remdesivir used under the terms of the EUA will be controlled by the US government and may only be supplied to authorized distributors or to US government agencies.
The EUA allows remdesivir to be used to treat adults and children with suspected or laboratory confirmed cases of COVID-19 with severe disease who have low levels of oxygen saturation (Sp02 ≤ 94%) or who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
The EUA also stipulates that remdesivir must be administered in an inpatient setting by a healthcare provider and must follow the dosing regimens detailed in the fact sheet for health care providers. A separate fact sheet must be provided to patients or their parents or caregivers.


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