Two weeks after Eli Lilly unveiled data showing its COVID-19 antibody cocktail of bamlanivimab and etesevimab slashed the risk of death and hospitalization for high-risk patients, the cocktail has won its emergency FDA authorization.
Tuesday, the FDA authorized the combo for patients who have mild to moderate cases of COVID-19 but are at high risk of progressing to severe disease. The company and its manufacturing partner Amgen aim to produce up to 1 million doses of the cocktail by the middle of the year.
In the trial of more than 1,000 high-risk patients with newly diagnosed COVID-19, just 11 patients who received the bamlanivimab-etesevimab combo were hospitalized and none died. That compared with 26 hospitalizations and 10 deaths among placebo patients, which translates into a 70% reduction in the risk of a COVID-19 hospitalization or death.
Further, separate phase 2 trial data showed similar effects from the FDA-authorized doses—700 mg for bamlanivimab and 1400 mg for etesevimab—compared with 2800-mg doses for each antibody. The data “provide confidence” in the authorized dose, Lilly said, which will help stretch supply.
In addition to the combo nod, which applies to patients 12 and older, the FDA authorized shorter infusion times for the cocktail—and for bamlanivimab alone—of 21 minutes and 16 minutes, respectively. Previously, bamlanivimab was authorized as a one-hour infusion. The FDA shortened the infusion time to reduce burdens on healthcare systems after hearing from front-line doctors and nurses.
As for supply, Lilly says 100,000 doses of the cocktail are available immediately and another 150,000 will be available by the end of March. The company has a partnership with Amgen to produce up to 1 million doses by midyear.
The cocktail is also authorized in Italy, and Lilly says it plans to continue scaling up production to make the meds available in more countries worldwide.
The combo nod followed an authorization for bamlanivimab alone in November in high-risk patients with mild to moderate cases. Since then, the drug has generated $871 million in revenues, and Lilly expects revenues of $1 billion to $2 billion for the antibody this year.
Aside from its antibodies, Lilly’s rheumatoid arthritis medicine Olumiant also carries an FDA emergency authorization in combination with Gilead’s Veklury in certain patients hospitalized with COVID-19.