FDA authorizes drug combination for treatment of COVID-19

FDA issued on Thursday an emergency use authorization (EUA) for baricitinib (Eli Lilly), in combination with remdesivir (Gilead Sciences), for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients aged 2 years or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorpore

FDA issued on Thursday an emergency use authorization (EUA) for baricitinib (Eli Lilly), in combination with remdesivir (Gilead Sciences), for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients aged 2 years or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. A clinical trial of hospitalized patients with COVID-19 found that baricitinib, in combination with remdesivir, reduced the time to recovery within 29 days after initiating treatment compared with patients who received a placebo with remdesivir. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. Baricitinib, a janus kinase inhibitor, is not authorized or approved as a stand-alone treatment for COVID-19. "Today's action demonstrates the FDA's steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective," said FDA Commissioner Stephen M. Hahn, MD. Under the EUA, fact sheets that provide important information about using baricitinib in combination with remdesivir in treating COVID-19 as authorized must be made available to health care providers and to patients and caregivers. The fact sheets include dosing instructions, potential adverse effects, and drug interactions. Possible adverse effects of baricitinib in combination with remdesivir include serious infections, blood clots, changes in certain lab test results, and allergic reactions.