Lilly's Covid-19 antibody cocktail granted EUA

The FDA has granted emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab (LY-CoV555) 700 mg and the antibody etesevimab (LY-CoV016) 1,400 mg together, Eli Lilly and Company announced. This comes after an EUA was previously issued for bamlanivimab alone, last November.

The combination therapy is approved 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. Lilly suggests that bamlanivimab and etesevimab be administered together via a single intravenous infusion as soon as possible, after a positive Covid test and within 10 days of symptom onset.

The EUA is based on Phase III data from the BLAZE-1 trial, formerly announced on Jan. 26, which demonstrated bamlanivimab and etesevimab together reduced the risk of  hospitalizations and death from the novel coronavirus by 70%.

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, which is down from the previously authorized time of 60 minutes. This decision came as a result of feedback from front-line nurses and doctors administering these infusions.

Standalone bamlanivimab is authorized in numerous countries, while bamlanivimab and etesevimab together is currently authorized in the US and Italy. Lilly, in partnership 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, and an additional 150,000 doses will be available throughout Q1.