Eli Lilly's bamlanivimab administered with etesevimab receives FDA emergency use authorization for COVID-19.

The FDA granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together, Eli Lilly and Company announced . This therapy is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes. This decision has been made in response to feedback received from front-line nurses and doctors administering these infusions and are aimed at reducing the burden on the healthcare system. The EUA is based on Phase III data from the BLAZE-1 trial, announced January 26, 2021, which demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent. These data replicate earlier results, published in The Journal of the American Medical Association, in a much larger group of patients. Additionally, the outcomes seen with bamlanivimab and etesevimab together are consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone. The most common adverse event more often reported for patients receiving bamlanivimab and etesevimab together versus placebo was nausea on the day of infusion. While Phase II and Phase III trials evaluated a range of doses of bamlanivimab alone and bamlanivimab and etesevimab together, data demonstrated consistent and similar clinical effects among all doses studied. Additionally, initial results from an ongoing Phase II study provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated bamlanivimab 700 mg and etesevimab 1400 mg together produced similar effects to those observed in the Phase III trial with bamlanivimab 2800 mg and etesevimab 2800 mg together. Together, these data provide confidence in the authorized dose, which expands available supply to help more patients without sacrificing potential efficacy. See: January 21, 2021-" Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19. A Randomized Clinical Trial"- Robert L. Gottlieb, MD, PhD; Ajay Nirula, MD, PhD; Peter Chen, MD; et al. JAMA. Published online January 21, 2021. doi:10.1001/jama.2021.0202.