FDA OKs Gilead’s Remdesivir as First Drug in US to Treat COVID-19

By Miranda Greenberg -

October 29, 2020

The US Food and Drug Administration (FDA) has approved Gilead Sciences’ antiviral drug, Veklury (remdesivir), for treating hospitalized COVID-19 patients, making it the first drug in the US to receive marketing authorization by the FDA to treat COVID-19. The drug was previously approved only for emergency use.

The full marketing approval for Veklury is for adult and pediatric patients (12 years of age and older and weighing at least 40 kg [88 pounds]) for the treatment of COVID-19 requiring hospitalization.

The new approval does not include the entire population that had been authorized to use Veklury under the FDA's emergency use authorization (EUA) originally issued on May 1, 2020. To cover the entire pediatric population under the EUA, the FDA revised its emergency use authorization for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.

Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide. Multiple ongoing international Phase III clinical trials are evaluating the safety and efficacy of Veklury for the treatment of COVID-19 in different patient populations, formulations, and in combination with other therapies.

As announced on October 1, 2020, Gilead says it is meeting real-time demand for Veklury in the US and anticipates meeting global demand for Veklury in October (October 2020), even in the event of potential future surges of COVID-19.

In its third-quarter 2020 results, Gilead reported sales of $873 million for Veklury.

Source: Gilead Sciences (Veklury approval), Gilead Sciences (third quarter results), and the US Food and Drug Administration