FDA Approves First COVID-19 Drug: Veklury
The Food and Drug Administration (FDA) approved the first drug for the treatment of COVID-19. The antiviral drug Veklury (remdesivir), manufactured by Gilead Sciences Inc., is approved for use in hospitalized adult and pediatric patients 12 years of age and older.
Veklury was previously issued as an emergency use authorization (EUA) in May 2020 following the National Institutes of Health’s clinical trial, which showed promising results in battling COVID-19. Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). In considering approval of a drug, the FDA conducts a risk-benefit assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population. This is different from the standard used in the issuance of an EUA.
“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 M. Hahn said in a news release.
The FDA granted Veklury Fast Track and Priority Review designations and a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological, and nuclear threats.