THURSDAY, Oct. 22, 2020 (HealthDay News) — The U.S. Food and Drug Administration has approved the first treatment for COVID-19.
Remdesivir, sold under the brand name Veklury, is approved for use in adults and children 12 years and older hospitalized with COVID-19. The drug is indicated for use only in a hospital or health care setting providing acute care comparable to inpatient hospital care. The FDA previously granted emergency use authorization to Veklury on May 1.
“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,” FDA Commissioner Stephen Hahn, M.D., said in an agency news release.
The emergency use authorization from May has been revised and reissued to Gilead Sciences Inc. to ensure continued access to Veklury for hospitalized pediatric patients with suspected or laboratory-confirmed COVID-19 who weigh 3.5 to <40 kg or hospitalized patients younger than 12 years and weighing at least 3.5 kg. Clinical trials of Veklury are ongoing for this patient population.
The FDA based the current approval on data from three randomized, controlled trials of patients hospitalized with mild-to-severe COVID-19. In ACTT-1, a randomized, double-blind, placebo-controlled trial of more than 1,000 patients conducted by the National Institute of Allergy and Infectious Diseases, median time to recovery from COVID-19 was 10 days for patients randomly assigned to Veklury plus standard of care and 15 days for those assigned to placebo plus standard of care.
In a second randomized, open-label multicenter clinical trial, hospitalized patients with moderate COVID-19 were randomly assigned to five days of treatment with Veklury (191 patients), 10 days of treatment with Veklury (193 patients), or standard of care (200 patients). The FDA reports that “the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group at Day 11 when compared to those receiving only standard of care.” In a third randomized, open-label multicenter clinical trial of 397 patients, on day 14, researchers found similar odds of a patient’s COVID-19 symptoms improving when treated with five days or 10 days of Veklury, and they found no statistically significant differences in recovery or mortality rates between the groups.
Possible side effects of Veklury include increased liver enzyme levels and allergic reactions, which could include changes in blood pressure and heart rate, low blood oxygen levels, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating, or shivering.
Approval was granted to Gilead Sciences Inc.