The U.S. Food and Drug Administration has granted an Emergency Use Authorization for two COVID-19 antibody therapies from Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The company says the combination of bamlanivimab and etesevimab can be used for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older who are at high risk for progressing to severe cases or hospitalization.
The EUA is based on the results of a Phase 3 clinical trial released last month that showed the combination of the two therapies reduced the risk of hospitalizations and death from COVID by 70%.
“Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit,” said Dr. Daniel Skovronsky, chief scientific officer for Lilly and president of Lilly Research Laboratories. “Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world.”
Lilly says the therapies should be administered together through a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of the onset of symptoms.
Additionally, the FDA has authorized shorter infusion times for bamlanivimab alone, and for the two therapies together. The previously-authorized time was 60 minutes; now, the infusion time can be as short as 16 minutes for bamlanivimab or 21 minutes for the combination.
Lilly says it is collaborating with California-based Amgen Inc. (Nasdaq: AMGN) to manufacture up to 1 million doses of etesevimab for use with bamlanivimab by mid-2021. The company currently has 100,00 doses ready for distribution and an additional 150,000 doses are expected to be available throughout the rest of the first quarter.
“As COVID-19 cases, hospitalizations and subsequent deaths continue to rise, we are committed to working with the U.S. government to supply our antibody therapies for use by patients across the country,” said Skovronsky.
In November, Lilly received an EUA for bamlanivimab as a single treatment, a move that was mirrored by Health Canada a few weeks later. The company says the authorizations are temporary and the treatments have not received FDA approval.