The U.S. Food and Drug Administration (FDA) has expanded the scope of its existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, whatever the severity of the disease.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity currently undergoing global trials as a cure for COVID-19. It was developed by California-based biopharmaceutical company Gilead Sciences, Inc. and is the first COVID-19 cure given an EUA by the FDA.
The EUA issued, in May, authorized remdesivir for the treatment of hospitalized adult and pediatric patients with severe COVID-19. Use of remdesivir was limited to patients with severe COVID-19, however.
FDA said its ongoing review of the EUA, it's determined it's reasonable to believe Veklury might be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients. Its review has, also, concluded the known and potential benefits of Veklury outweigh the drug's known and potential risks.
"The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients," said FDA Commissioner Dr. Stephen Hahn. "The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus."
Gilead Sciences said the expanded EUA is based on results from the Phase 3 "SIMPLE trial" evaluating Veklury in hospitalized patients with moderate COVID-19, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.
Dr. Merdad Parsey, Chief Medical Officer at Gilead Sciences, said the company welcomes the FDA's decision to expand emergency use authorization. He said the FDA's action will allow doctors to consider a broader range of eligible patients to potentially receive remdesivir.
Results from the Phase 3 SIMPLE study were published in the Journal of the American Medical Association (JAMA) on August 21. The study confirms top-line results previously announced June 1.
The JAMA study shows remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. It showed that at Day 11 on a 7-point ordinal scale, patients randomized to a 5-day course of Veklury plus standard of care were 65% more likely to have an improvement in clinical status compared with those randomized to standard of care alone.
