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The U.S. Food and Drug Administration (FDA) on Monday gave emergency approval to Eli Lilly's investigational monoclonal antibody treatment for coronavirus.
The therapy called bamlanivimab, given via one IV infusion, was authorized for patients over 12 at high risk for hospitalization or a severe course of COVID-19. This includes patients older than 65 with serious underlying health conditions.
"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," said David A. Ricks, chairman and CEO of Eli Lilly, in a company news release.
The FDA on Monday gave emergency approval to Eli Lilly’s investigational monoclonal antibody treatment for coronavirus. (iStock)
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Lilly officials said the treatment should be given to patients as soon as possible after a positive diagnosis, and within about 10 days of symptoms, per the release.
“While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the FDA wrote in a news release. More specifically, Lilly noted the data stems from a randomized, double-blind Phase 2 trial called BLAZE-1, but added that some patients had reactions to the infusions, among other "allergic hypersensitivity events."
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"The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," Dr. Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories, said in the company release.
The therapy isn’t approved for hospitalized coronavirus patients or those requiring oxygen due to the disease; it is approved for those with a mild to moderate course of the disease.
Lilly disclosed plans to promptly start shipping the therapy to AmerisourceBergen, where it will distribute it as directed by the U.S. government.
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