The pharmaceutical company Eli Lilly said Wednesday it has requested emergency authorization from the Food and Drug Administration (FDA) for an antibody treatment for the coronavirus.
The company said it had submitted an initial request to the FDA for its antibody treatment, which was derived from a blood sample of a patient who recovered from the coronavirus. The treatment essentially injects a manufactured version of one of the body’s tools for fighting the virus into patients.
The company is asking for emergency authorization for higher-risk patients who have recently been diagnosed with “mild to moderate COVID-19.” The company said last month that data from a phase two study showed the treatment reduced the hospitalization rate for people who received it.
Antibody treatments are viewed as promising, and President Trump received a similar treatment last week made by a competitor company, Regeneron.
Eli Lilly also reported data on Wednesday for a treatment using a combination of two antibodies, as opposed to the single antibody on which it applied for emergency authorization. The company said the combination treatment reduced levels of the virus in patients and rates of hospitalization. It said it expects to file for emergency authorization for that treatment in November.
For the single antibody treatment, Eli Lilly said it expects it could have 100,000 doses available in October, if it receives FDA authorization, and one million doses in the fourth quarter of 2020.
“Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments,” said Daniel Skovronsky, Eli Lilly’s chief scientific officer. “We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available.”