Gilead’s Antiviral Drug “Remdesivir” receives Emergency Use Authorization (EUA) letter from USFDA for the treatment of COVID-19

Gilead’s Antiviral Drug “Remdesivir” receives Emergency Use Authorization (EUA) letter from USFDA for the treatment of COVID-19

Gilead’s Antiviral Drug “Remdesivir” receives Emergency Use Authorization (EUA) letter from USFDA for the treatment of COVID-19.

Remdesivir is a nucleoside ribonucleic acid (RNA) polymerase inhibitor. Remdesivir shall be administered through parenteral route (Product is available in the form of preservative-free lyophilized solid that is to be reconstituted with sterile water for injection and diluted into saline prior to intravenous (IV) administration).

Remdesivir is a direct acting antiviral drug that inhibits viral RNA synthesis. It is an investigational drug and is not currently approved for any indication. Remdesivir has activity in cell culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2.

 In the letter issued to Gilead on 1^st May 2020, FDA states that “Based on review of the top line data from the randomized, double-blinded, placebo-controlled trial conducted by NIAID (NCT04280705) and from the Gilead-sponsored open-label trial that evaluated different durations of remdesivir (NCT04292899), it is reasonable to believe that the known and potential benefits of RDV outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19”.

Emergency use authorizations (EUAs) are one of several tools USFDA is using to make important medical products available quickly on a public health emergency.

 Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved and available alternatives.

EUA process is different than full approval procedure, because in some emergency situation, agency cannot wait for all the evidence need for new drug approval. Instead the FDA evaluates the options very quickly using the evidence that is available and carefully balances any known or potential risks these unproven products with any known or potential benefits to the public of making them available during the emergency.

 Abbreviations

CBRN - 'CBRN' is the abbreviation commonly used to describe the malicious use of Chemical, Biological, Radiological and Nuclear materials or weapons with the intentions to cause significant harm or disruption.