Remdesivir has become the first drug to be approved by The Food and Drug Administration (FDA) to treat hospitalised COVID-19 patients.
On Thursday [October 22], the FDA explained that remdesivir, sold under brand name Veklury, is approved for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalisation.
Remdesivir is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. It has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19.
The approval of remdesivir was supported by the agency’s analysis of data from three randomised, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. One of the three trials found that the recovery time for patients receiving remdesivir was shorter than those receiving a placebo.
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 benefit-risk 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.
In May, the drug was granted an emergency use authorisation to allow healthcare providers to administer the treatment despite it lacking formal approval.
The drug has seemingly polarised the medical community. Just last week, the World Health Organization (WHO) released a study that found that remsesivir, along with other tested drugs like Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay