At the beginning of the pandemic in 2020, Eli Lilly, a pharmaceutical company, joined forces with Junish Bioscience, a Chinese biopharmaceutical company, and AbCellera, a Canadian biotechnology organization, to develop two COVID-19 antibody drugs.
Eli Lilly succeeded and received FDA clearance for both antibody drugs. The first drug that was cleared by the FDA was bamlanivimab, a single antibody drug. The second drug combined bamlanivimab with etesevimab. The second FDA-cleared antibody drug was developed to be more effective and efficient at targeting mutating viruses, like the delta variant of COVID-19.
Four months after clearance from the FDA, in late June, the organizations were told to stop production on both drugs as the spread of the variants, like the beta, delta, and gamma variants, were not something the antibody drugs could neutralize. About 96% of US COVID cases right now are due to a variant, specifically the delta variant. US officials claimed that the halt in production was due to a lack of effectiveness against variants.
The antibody drug is now being used in states where the gamma and beta variants are not as prevalent. The FDA revised Eli Lilly’s antibody drug and mentioned that the drug will not be used in states where the gamma or beta variant is 5% or greater.
The 22 states that meet the 5% rule imposed by the FDA include: Connecticut, Colorado, Indiana, Illinois, Kansas, Maine, Iowa, New Hampshire, Massachusetts, Minnesota, Michigan, Montana, North Dakota, Minnesota, Missouri, Rhode Island, Ohio, Utah, Vermont, Wyoming, and Wisconsin. 1
To learn more about quality, regulatory, or compliance, EMMA International’s team of experts has you covered. Contact us at 248-987-4497, or email email@example.com today!
1FDA restarts distribution of Lilly’s COVID-19 drug in 22 states. (n.d.). MedTech Dive. Retrieved September 13, 2021, from https://www.medtechdive.com/news/lilly-covid-antibody-fda-restart-distribution/605883/