FDA Authorizes Lilly’s COVID-19 Antibody Cocktail for Emergency Use
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Eli Lilly and Company’s investigational combination therapy for the treatment of COVID-19, bamlanivimab (700 mg) and etesevimab (1,400 mg).
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. Under the authorization, 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.
The EUA is based on Phase III data that demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%. 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
Bamlanivimab alone is authorized in numerous countries while bamlanivimab and etesevimab together is currently authorized in the US and Italy. Lilly says it will continue working with global regulators to make these therapies available globally.
Manufacturing and supply
Lilly says it will continue to supply bamlanivimab alone under the authorizations granted in various countries while continuing to accelerate manufacturing of etesevimab for global use. Lilly, in collaboration with Amgen, plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021. There are 100,000 doses ready immediately (as reported on February 9, 2021), and an additional 150,000 doses will be available throughout the first quarter of 2021.