FDA grants emergency use authorization for Eli Lilly COVID-19 treatment
The FDA announced on Monday it has issued an emergency use authorization for Eli Lilly's antibody therapy, bamlanivimab, to treat mild to moderate cases of COVID-19.
Why it matters: The treatment is authorized for people "who are at high risk for progressing to severe COVID-19 and/or hospitalization," including people who are 65 and older, and/or people with certain chronic illnesses.
- "[T]he safety and effectiveness of this investigational therapy continues to be evaluated," the FDA wrote in a news release, but the drug was shown to reduce coronavirus-related hospitalizations or emergency room visits for high-risk patients within 28 days after treatment.
- It's not authorized for people who are already hospitalized or are receiving oxygen.
What they're saying: “As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen Hahn.
- Eli Lilly Chairman and CEO David Ricks said in a statement, "This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic."
- Eli Lilly said it would immediately begin shipping bamlanivimab to AmerisourceBergen, which will distribute the drug as directed by the U.S. government's allocation program.
Worth noting: Eli Lilly announced in October that it sold the U.S. government 300,000 vials of bamlanivimab for $375 million, pending the FDA's emergency authorization.