bamlanivimab and etesevimab together

Bamlanivimab and etesevimab have not been approved, but have only been authorized for emergency use by Food and Drug Administration (FDA) for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab and etesevimab under Section 564(b)(1)(C) of the Act, 21 U.S.C. § 360bbb-3, unless the authorization is terminated or revoked sooner.

Bamlanivimab and etesevimab are authorized to be administered together in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe coronavirus disease 2019 (COVID-19), including hospitalization or death for

the treatment of mild to moderate COVID-19, or

post-exposure prophylaxis of COVID-19.

For information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com.

Bamlanivimab and etesevimab are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%, as determined by FDA. A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website: https://www.fda.gov/media/151719/download.