The U.S. Food and Drug Administration has granted an Emergency Use Authorization for a COVID-19 antibody therapy developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The treatment, known as bamlanivimab or LY-CoV555), is authorized for the treatment of mild-to-moderate COVID-19 in patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to a more severe case of the disease and/or hospitalization.
Lilly says the EUA is based on a Phase 2 study involving recently-diagnosed, mild-to-moderate COVID-19 in an outpatient setting.
“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,” Dave Ricks, chief executive officer of Lilly, said in a news release. “The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most.”
Lilly says the treatment should be administered as soon as possible after a COVID-19 test and within 10 days of the onset of symptoms. Dr. Daniel Skovronsky, chief scientific officer for Lilly and president of Lilly Research Laboratories, says when given early, the treatment may help patients clear the virus and reduce COVID-related hospitalizations.
Lilly says it will begin shipping the treatment immediately to AmerisourceBergen, which will distribute it as directed by the U.S. government.
Additionally, Lilly expects to manufacture up to one million doses of bamlanivimab by the end of the year, for use around the world through early 2021. The U.S. government says it will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs.
Because it is not an official FDA approval, an EUA allows a treatment to be used on a temporary basis given certain circumstances. Lilly says it does not replace the formal review and approval process and bamlanivimab remains an investigational drug.
The treatment continues to be studied in other clinical trials covering a variety of patient populations impacted by COVID-19. The company says the results of the trials could be used to support a future Biologics License Application with the FDA.
One trial involving bamlanivimab was canceled late last month. The study was sponsored by the National Institute of Allergy and Infectious Diseases, which said the treatment showed a “lack of clinical benefit” for patients who have been hospitalized with COVID-19.