Antibody Playbook

Lilly Bamlanivimab Antibody Playbook ELI LILLY AND COMPANY | NOVEMBER 2020 For the Emergency Use Authorization of bamlanivimab for the treatment of COVID-19 The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of bamlanivimab to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved product, bamlanivimab, for the treatment of COVID-19. • Bamlanivimab has not been approved, but has been authorized for emergency use by FDA, to treat mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. • Bamlanivimab is authorized for the treatment of mild to moderate COVID19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. • The FDA issued this EUA, requested by Eli Lilly and Company and based on their submitted data. Find more information in the FDA Letter of Authorization. • Health care providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. • Health care providers should review the Fact Sheet for Healthcare Providers for important information on the use of bamlanivimab. Lilly Bamlanivimab Antibody Playbook | 1 PP-BM-US-0024