FDA Approves First COVID-19 Treatment

The FDA has approved the antiviral Veklury (remdesivir) for the treatment of adult and pediatric patients aged 12 years or older who weigh at least 40 kilograms with COVID-19 who require hospitalization.

This is the first drug to be approved by the FDA for the treatment of COVID-19. However, this approval does not include all of the population allowed to use the drug under the FDA’s Emergency Use Authorization from May 2020. The authorization has now been revised to cover pediatric patients weighing less than 40 kilograms or those who re less than 12 years of age or weighing at least 3.5 kilograms.

The approval was based upon data from 3 randomized, controlled clinical trials of hospitalized patients with mild-to-severe COVID-19. The first showed that remdesivir was associated with a significantly shorter median time to recovery compared with placebo (10 days vs 15 days). The second showed that odds of symptom improvement were significantly higher at day 11 in patients given 5 days of the drug compared to those undergoing standard care. In the third, 5-day treatment with remdesivir was associated with similar outcomes to 10-day remdesivir treatment.

Possible adverse effects include increased liver enzymes and allergic reaction which could include blood pressure and heart rate changes, low blood oxygen levels, fever, shortness of breath, swelling, rash, nausea, sweating, and shivering.

“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks,” said FDA Commissioner Stephen M Hahn, MD.

—Michael Potts

Reference:

FDA approves first treatment for COVID-19. News release. October 22, 2020. US Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19