U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury (remdesivir) for Treatment of COVID-19 - Seite 3
The incidence of adverse events associated with Veklury was similar to placebo in the ACTT-1 trial. Rates of serious adverse events (SAEs) were numerically higher in the placebo group compared with the Veklury group. Treatment discontinuation, all-cause grade 3 and 4 adverse events (AEs) and laboratory abnormalities were similar across groups. In the SIMPLE-Severe trial, the most common adverse reactions occurring in at least 5% of subjects in either the Veklury 5-day or 10-day group, respectively, were nausea (5% vs 3%), AST increased (3% vs 6%), and ALT increased (2% vs 7%). In the SIMPLE-Moderate trial, the most common adverse reaction occurring in at least 5% of subjects in the Veklury groups was nausea (7% in the 5-day group, 4% in the 10-day group).
In parallel with the FDA approval of Veklury, the FDA also issued a new Emergency Use Authorization (EUA) for the use of Veklury to treat hospitalized pediatric patients under 12 years of age weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory confirmed COVID-19 for whom use of an intravenous (IV) agent is clinically appropriate. This authorization is temporary and may be revoked, and does not take the place of the formal submission, review and approval process for the use of Veklury in this patient population. The use of Veklury in pediatric patients under 12 years of age or weighing less than 40 kg has not been approved by FDA, and the safety and efficacy of Veklury for this use has not been established. For information about the authorized use of Veklury in pediatric patients and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
About the ACTT-1 Trial
The global, randomized, double-blind, placebo-controlled, Phase 3 clinical trial ACTT-1 (NTC04280705) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) evaluated the efficacy and safety of a 10-day treatment course of Veklury versus placebo in 1,063 hospitalized adult patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 who also were receiving treatment with standard of care.
The primary outcome measure of ACTT-1 was time to recovery within 29 days after randomization. Recovery was defined as discharged from the hospital without limitations on activities, discharged from the hospital with limitations on activities and/or requiring home oxygen, or hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care.