FDA efficiency for approval process of COVID-19 therapeutics

Cassidy, Christine; Dever, Danielle; Stanbery, Laura; Edelman, Gerald; Dworkin, Lance; Nemunaitis, John

Coronavirus disease 19 (COVID-19) is an infection caused by the novel Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). The pandemic spread of SARS-CoV-2 has resulted in significant health, economic, and social ramifications. There are no U.S. Food and Drug Administration (FDA)-approved prophylactic or therapeutic treatment options for COVID-19. This puts unprecedented product development pressure on the medical science community to define treatment options. Additionally, in the United States of American (USA) further regulatory and quality assurance pressures impact the FDA. The regulatory therapeutic development process is complex as it relates to product mechanism, toxicity profile, and level of efficacy. The advert of a worldwide pandemic however, advanced efficiencies within many of the regulatory agencies worldwide in order to facilitate COVID-19 treatment option development within the USA. Clinical drug development pathways can include several established approaches: investigational new drug (IND), expanded access IND, emergency IND, treatment IND, and emergency use authorization (EUA). Remdesivir, an investigational drug, and hydroxyloroquine, an FDA-approved drug for autoimmune diseases, were the two early potential therapies. This review article examines the expedited FDA review process for remdesivir and hydroxychloroquine, and analyzes data and results from early clinical studies of both drugs.