FDA Approves Remdesivir as First Therapeutic Treatment for Covid — One Week After WHO Concludes Drug Has ‘Little to No Effect’ on Patient Survival

Photo credit: Olivier Douliery, AFP via Getty Images.

On Thursday, the Food and Drug Administration granted full approval to treat coronavirus to Gilead Sciences’ antiviral drug remdesivir — one of the drugs used to treat President Donald Trump when he contracted the virus three weeks ago.

According to CNBC, the FDA has now authorized the use of the drug for all hospitalized Covid-19 patients at least 12 years old, making remdesivir the only drug currently approved as a therapeutic for the virus. For the past five months, the drug, along with a few others, have been dispensed under an emergency use authorization.

As the Covid case rate spikes again for the third time this year — and the seven-day average has surged past 60,000 new daily cases — Gilead said it is ramping up production to try to meet the growing case load and hospitalizations.

In August, the company said it planned to produce more than 2 million treatment courses of remdesivir by the end of the year and anticipated being able to make “several million more” in 2021, adding it has increased the supply of the drug more than fiftyfold since January. Its manufacturing network now includes more than 40 companies in North America, Europe and Asia.

There is one notable caveat to the FDA’s move, however. Just last week, the World Health Organization concluded that remdesivir had “little to no effect” on the survival rate of coronavirus patients in one of its recent trials. That trial, which has yet to be peer reviewed, included more than 10,000 Covid patients in 500 hospitals across 30 countries. Gilead pushing back, claimed the results of the study were “inconsistent.”