FDA Approves Veklury (remdesivir) As The First Treatment For COVID-19

On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved by FDA to treat COVID-19. Originally intended to treat Ebola, Veklury has been shown to reduce the severity and length of COVID-19 in certain patients. Veklury is only approved for patients meeting certain criteria relating to age and weight, but additional research is being performed to evaluate whether it can be an effective treatment for all persons suffering from COVID-19.

Veklury is a treatment for those who have already contracted COVID-19 and not a vaccine to prevent the virus.

FDA approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). FDA performs a benefit-risk assessment in determining whether new drugs should be approved. In the case of Veklury, FDA analyzed data from three separate randomized clinical trials in determining that the benefits of Veklury outweigh its risk for the intended population.

FDA limits Veklury to patients “requiring hospitalization.” More specifically, Veklury is approved for “use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.” Further testing and trials are being conducted under an Emergency Use Authorization (EUA) to determine if Veklury is safe and effective for patients under 12 years of age.

Veklury was originally granted an EUA on May 1, 2020. The original EUA authorized use of Veklury for patients with severe disease. Following positive results from clinical trials, FDA reissued the EUA several times, expanding the scope of authorized use to treat more patients.

In conjunction with approval of Veklury in patients over 12 years of age, FDA reissued the EUA on October 22, 2020 to authorize the use of Veklury in “pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.”

The authorization of Veklury in a shortened time frame is a result of various FDA programs aimed at expediting review and authorization of life saving drugs. Indeed, FDA granted the Veklury application both Fast Track and Priority Review designations. In addition, FDA granted the application a Material Threat Medical Countermeasure Priority Review Voucher which provides incentives for review of drugs intended to treat or prevent threats such as COVID-19.

As the COVID-19 crisis continues, Seyfarth Shaw attorneys are closely monitoring FDA’s reactions to the situation. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our Resource Center for more information.