Eli Lilly has ended a trial of its COVID-19 antibody drug, bamlanivimab, that tested the drug’s effectiveness in treating hospitalized COVID-19 patients, a month after an interim analysis suggested the drug helped the virus leave patients’ systems sooner.
The drug was shown to have no effect on recovery times or survival rates for patients hospitalized with advanced COVID-19, but it will continue to be tested for other COVID-19 patients.
A timeline of Eli Lilly’s development of bamlanivimab:
June 1: Eli Lilly begins testing an experimental drug derived from antibodies in a COVID-19 survivor’s blood.
Aug. 3: Eli Lilly says it has begun phase 3 testing of its COVID-19 antibody drug and will begin testing it in nursing homes and assisted living facilities.
Aug. 4: The National Institutes of Health picks Eli Lilly’s antibody drug to be the first in a wide-ranging series of studies on monoclonal antibodies.
Sept. 16: An interim analysis of Eli Lilly’s drug shows that it helped the virus leave COVID-19 patients’ systems sooner.
Sept. 17: Eli Lilly partners with Amgen to boost manufacturing capacity for the drug, which it has named bamlanivimab.
Oct. 7: Eli Lilly submits a request for an emergency use authorization from the FDA for use of bamlanivimab in higher-risk patients recently diagnosed with mild to moderate COVID-19
Oct. 8: Eli Lilly partners with the Bill & Melinda Gates Foundation to supply bamlanivimab to low- and middle-income countries.
Oct. 13: Eli Lilly’s clinical trial of bamlanivimab is paused due to a safety concern.
Oct. 14: The NIH says Eli Lilly’s trial was halted due to the “clinical status” of multiple participants. An independent safety board says that after five days of treatment, it found the group of patients who had received bamlanivimab showed a different “clinical status” than the group who received the placebo, and the difference crossed a predetermined threshold for safety.
Oct. 20: Bloomberg reports that FDA inspectors had found quality control issues with an Eli Lilly plant in New Jersey making bamlanivimab earlier in the month.
Oct. 26: Eli Lilly says it won’t continue the trial halted Oct. 13 after data showed bamlanivimab doesn’t improve recovery times or survival rates for patients hospitalized with advanced COVID-19. Other trials testing the drug will go on to test its effectiveness for patients who haven’t been exposed to COVID-19 or who have milder cases of the disease. The drugmaker hasn’t released any information on the clinical status of the participants who caused the trial to halt.
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