Page 2 – Eli Lilly and Company used under the conditions described in this authorization, the known and potential benefits of bamlanivimab outweigh the known and potential risks of such product. Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of bamlanivimab for treatment of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. I. Criteria for Issuance of Authorization I have concluded that the emergency use of bamlanivimab for the treatment of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: 1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; 2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that bamlanivimab may be effective in treating 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, and that, when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab outweigh the known and potential risks of such product; and 3. There is no adequate, approved, and available alternative to the emergency use of bamlanivimab for the treatment of 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.3 II. Scope of Authorization I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows: x Distribution of the authorized bamlanivimab will be controlled by the United States (U.S.) Government for use consistent with the terms and conditions of this EUA. Lilly will supply bamlanivimab to authorized distributors4, who will distribute to healthcare facilities or healthcare providers as directed by the U.S. Government, in collaboration with state and local government authorities, as needed; 3 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act. 4 “Authorized Distributor(s)” are identified by Lilly as an entity or entities allowed to distribute authorized bamlanivimab. Reference ID: 4699500