More information is needed to determine whether Eli Lilly's COVID-19 antibody drug, which received emergency authorization from the FDA Nov. 9, is safe and effective, and it's important for the public to understand that initial supply of the drug will be limited, the Infectious Diseases Society of America said Nov. 12.
Barbara Alexander, MD, president of the society, said its COVID-19 treatment and management guideline panel is evaluating the data on which the emergency authorization was given and will issue recommendations for its use.
"It is important for clinicians and members of the public to be aware that the available data are limited, and that more information is needed to determine the effect of this therapy on clinically meaningful outcomes," the society said.
The society is urging clinical trials to continue to determine the drug's safety and efficacy and said it is concerned the benefits of the drug will be limited by its scarcity and the logistics of administering it.
The drug must be given in an outpatient setting with close monitoring from providers, but health officials have said they don't want the drug to be given in traditional infusion centers because they don't want cancer patients in the same place as COVID-19 patients.
The society strongly urges that "significant steps be taken to prevent serious inequities in the patient populations who will have access" to the drug.
Steps include monitoring people getting the drug and building delivery systems beyond hospital settings.
Read the full statement here.