Gilead Sciences' Remdesivir for combating SARS-CoV-2 (COVID-19)

Driven by the emergence of Coronavirus Disease 2019 (COVID-19) first identified in December 2019, the pharmaceutical industry and the scientific community has been put into overdrive with the sole purpose of finding a solution to this global pandemic. To date globally, as of 2:00am CEST, 23 April 2020, there have been 2,549,632 confirmed cases of COVID-19, including 175,825 deaths, reported to WHO.

Of the leading drugs, Gilead Sciences has been working on repositioning Remdesivir, initially developed during the Ebola Virus epidemic in 2013 to 2016 and also used in an emergency setting for the Kivu Ebola epidemic in 2018. Subsequently drug has been discovered to have antiviral activity invitro against multiple filo-, pneumo-, paramyxo-, and corona- viruses. If the drug is to be approved, concerns are on the capacity of the company to meet demand. CEO Daniel O'Day indicated Gilead had enough active ingredient to make 1.5 million doses enough for an estimated 140,000 treatment courses based on a 10 day regimen. Gilead has been open about challenges they are facing in manufacturing the drug, stating it typically takes 9 to 12 months to manufacture an antiviral similar to remdesivir. As the drug was developed during the Ebola virus outbreak, Gilead was not inclined to make the synthesis as efficient as possible, reflecting on the anticipated demand for the drug. With the current Corona Virus cases surpassing 2.5 million under 6 months the demand is extremely high and the company is seemingly working optimizing the chemical synthesis process. This drug as an FDA orphan designation for the treatment of Ebola, it does have FDA approval as of yet.

Remdesivir

REMDESIVIR

Gilead has initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing. The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing duration of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19 [https://clinicaltrials.gov/ct2/show/NCT04292899]. The second study will evaluate the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone [https://clinicaltrials.gov/ct2/show/NCT04292730].