Eli Lilly’s COVID-19 Antibody Reduces Hospitalizations by 87%

Eli Lilly & Company recently announced new data showing that its combination COVID-19 antibody therapy significantly reduced COVID-19 hospitalizations and deaths in high-risk coronavirus patients. 

The BLAZE-1 Phase 3 clinical trial enrolled 769 high-risk patients 12 years of age and older with mild to moderate COVID-19. Patients received either bamlanivimab at 700 milligrams and etesevimab at 1400 milligrams together or a placebo. 

In the trial, there were four events in the antibody combination group and 15 events in the placebo group, representing an 87 percent risk reduction. The antibody combination also demonstrated statistically significant improvements on key secondary endpoints. 

The new data from the BLAZE-1 Phase 3 clinical trial provides additional efficacy and safety results that support the use of the dosage recently granted FDA emergency use authorization.

"These positive results reinforce our previous findings and support the authorized dose of bamlanivimab 700 mg with etesevimab 1400 mg,” Daniel Skovronsky, MD, PhD, Eli Lilly & Company’s chief scientific officer and president of Lilly Research Laboratories. 

"The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the U.S,” Skovronsky continued. 

Eli Lilly & Company’s new data also supports the positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the antibody combination, which was published at the beginning of March. 

The CHMP based its opinion on Phase 2 and Phase 3 results from the BLAZE-1 trial announced at the beginning of February. 

In the trials, patients received 2,800 milligrams of bamlanivimab and 2,800 milligrams of etesevimab together. 

In the Phase 3 cohort, bamlanivimab at 2,800 milligrams with etesevimab at 2,800 milligrams reduced the risk of hospitalizations and deaths by 70 percent, while in the Phase 2 cohort, bamlanivimab alone reduced the risk of hospitalizations and ER visits by nearly 70 percent. 

The viral load reductions were also consistent with what was observed in the previous Phase 3 cohort of the study, researchers explained. Therefore, overall results are consistent with those seen in other data sets from BLAZE-1.

There were only 11 adverse events in patients taking the therapy and 36 events in patients taking the placebo. Notably, the ten deaths that were reported in the study all took place in the placebo group.

Overall, the drug combination demonstrated statistically significant improvement on all key secondary endpoints, reduced viral load, and boosted symptom resolution.

“These compelling data – in addition to the recent EUA from FDA, the CHMP decision from EMA and the recommendation for the therapy in the National Institutes of Health's COVID-19 Treatment Guidelines – give healthcare providers additional information regarding the use of bamlanivimab and etesevimab together as a potentially life-saving treatment to help those most at risk for severe complications of COVID-19," Skovronsky said. 

Eli Lilly & Company stated that it will continue to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available globally. 

At the end of February, Eli Lilly & Company partnered with local health systems to enhance access to crucial COVID-19 antibody therapies. The partnership will work to launch dedicated infusion center locations in northern and southern Indiana to provide individuals with access to coronavirus treatments.

The company also partnered with Community Health Network, Eskenazi Health, and Franciscan Health on an infusion center serving central Indiana, and with Saint Joseph Health System, Beacon Health System, and Goshen Health System on an infusion center in northern Indiana. 

So far, these infusion centers have helped to eliminate treatment barriers by delivering COVID-19 antibody therapies to over 1,700 coronavirus patients living in Indiana who are high risk.