Story at a glance
- An antibody drug created by pharma company Eli Lilly was approved for emergency use for COVID-19 cases.
- Officials note that some hypersensitive allergic reactions were seen in Phase 2 trials.
The Food and Drug Administration (FDA) has approved the first antibody drug for emergency use to help stimulate an immune reaction in COVID-19 patients to fight off the virus.
The drug, called bamlanivimab, is an experimental treatment created by Eli Lilly. It is now cleared by the FDA for patients aged 12 or older with mild to moderate cases of COVID-19, the company stated in a press release.
Patients must also provide a positive COVID-19 test result to receive the medication, and be at risk for a severe infection. The antibody treatment aims to neutralize COVID-19 particles detected in the body.
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“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,” David A. Ricks, Eli Lilly’s chairman and CEO, said in prepared remarks. “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.”
The FDA approved bamlanivimab for emergency use following data from a randomized double-blind Phase 2 clinical study that showed COVID-19 patients who received the drug had less viral loads and lower rates of symptom onset and hospitalization.
Notably, the study saw some patients develop allergic reactions to bamlanivimab, prompting the emergency use authorization (EUA) to carry a warning with the drug.
Because the treatment is experimental, Eli Lilly cannot guarantee that bamlanivimab is “safe and effective for the treatment of COVID-19.”
Officials also note that there is still “limited clinical data” for bamlanivimab, and serious adverse reactions are a possibility.
Daniel Skovronsky, the chief scientific officer and president of Lilly Research Labs, said that the trial data suggests that when administered early in the infection, the drug may help clear the virus and reduce COVID-19 hospitalizations, which have been rising in the U.S. along with new cases.
“We’re proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19,” Skovronsky added. “We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.”
The next step for bamlanivimab will be distribution, which will be directed by the U.S. government’s allocation program.
Eli Lilly gained national prominence when it administered its antibody treatment to President Trump following his COVID-19 diagnosis and hospitalization.
This is the latest big pharmaceutical news to be announced this week. Earlier, pharmaceutical manufacturers Pfizer and Novavax reported progress with their COVID-19 vaccine candidates.
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