FDA approves remdesivir, first treatment for COVID-19
The FDA has approved Gilead Science’s antiviral IV drug remdesivir — also known as Veklury — for adults and children aged older than 12 years when treatment of COVID-19 requires hospitalization.
The drug is the first approved therapy for COVID-19.
The approval of remdesivir does not extend to the entire population that had been authorized to use it under an emergency use authorization that was issued May 1, the agency said.
According to a press release, the approval of remdesivir was based on three randomized controlled trials. In the first trial, 1,062 patients received standard-of-care treatment plus either remdesivir or placebo. The second trial included 584 patients who received remdesivir or standard of care. In the last trial, 397 patients received remdesivir for either 5 or 10 days. Patients in all three trials who received remdesivir improved; however, not all improvements were statistically significant.
Interim results from the Solidarity Therapeutics Trial, a randomized study coordinated by WHO in more than 30 countries, indicate that remdesivir, along with other repurposed drugs like hydroxychloroquine, lopinavir/ritonavir and interferon regimens, appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.
According to the FDA, possible adverse events associated with remdesivir use include higher levels of liver enzymes and allergic reactions. Specifically, allergic reactions could include changes in BP and heart rate; fever; low blood oxygen level; nausea; rash; shivering; shortness of breath; sweating; swelling around the eyes, lips and/or under the skin; and wheezing. The drug should only be administered to patients weighing more than 88 pounds in hospitals and other health care settings that can provide acute care resembling inpatient hospital care.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” Stephen M. Hahn, MD, FDA commissioner, said in the press release. “The agency will 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.”
- FDA. FDA approves first treatment for COVID-19. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19?utm_medium=email&utm_source=govdelivery. Accessed October 23, 2020.
- WHO. Solidarity Therapeutics Trial produces conclusive evidence on the effectiveness of repurposed drugs for COVID-19 in record time. https://www.who.int/news/item/15-10-2020-solidarity-therapeutics-trial-produces-conclusive-evidence-on-the-effectiveness-of-repurposed-drugs-for-covid-19-in-record-time. Accessed October 23, 2020.