The Food and Drug Administration (FDA) on Monday granted its first emergency use authorization for an experimental coronavirus (COVID-19) antibody treatment made by the pharmaceutical company Eli Lilly.
The drug, called bamlanivimab, is meant to be used in patients 12-years-old and up with mild or moderate COVID-19 who do not yet require hospitalization, the FDA said in a release on Monday, adding that the treatment is specifically meant to treat people at high risk for developing more severe symptoms — including those 65 and older who have chronic medical conditions.
The treatment is administered through a one-time IV and is still undergoing testing to fully determine its safety and effectiveness, the FDA said, but has been “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 said bamlanivimab is not authorized to be used for patients who are hospitalized with COVID-19, or for those who require oxygen due to the disease.
The timing of the treatment is pivotal, the pharmaceutical company said in a release, explaining it should be given to the proper patients as soon as possible after a positive test and within 10 days of symptom onset.
“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, Eli Lilly’s chairman and CEO.
“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,” Ricks added.
Dr. Daniel Skovronsky, Eli Lilly’s chief scientific officer and president of Lilly Research Laboratories, said the treatment “may help patients clear the virus and reduce COVID-related hospitalizations.”
An emergency use authorization is not equal to FDA approval, and while the agency normally requires “substantial evidence” to show that a drug is safe and effective, public health emergencies enable the FDA to lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks.
To win full approval, Eli Lilly will have to submit additional research to fully show the drug’s safety and benefit for patients.
Regeneron Pharmaceuticals Inc. also has asked for emergency authorization for an antibody drug it is testing, the one President Donald Trump received after he contracted the virus in October.
The U.S. government previously reached an agreement in October with Eli Lilly to buy and supply much of the early production of the treatment, and Eli Lilly said it would immediately begin shipping the drug to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government’s allocation program.
“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” said Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”
The emergency use authorization comes at a particularly fraught period of the coronavirus outbreak in the U.S. Over 10 million Americans are confirmed to have contracted the virus, according to Johns Hopkins University, and more than 238,000 have died in the country.
In New York, Mayor Bill de Blasio on Monday issued a dire warning — saying the second wave is “getting dangerously close.” Staten Island has seen concerning increases in daily case totals recently, and deaths have also begun to creep upward.
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