FDA Approves Eli Lilly Coronavirus Antibody Treatment for Emergency Use

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The Food and Drug Administration (FDA) approved Eli Lilly’s coronavirus antibody treatment for emergency use.

The monoclonal antibody treatment, called bamlanivimab, is targeted at adults and children over the age of 12 with mild to moderate illness but who are at risk of hospitalization, according to the FDA’s letter of authorization.

The therapy is also meant for people with preexisting health conditions, such as diabetes, chronic kidney disease, sickle cell disease, or anyone over the age of 65.

The FDA’s authorization expands doctors’ ability to use the Eli Lilly treatment outside of clinical trials.

The drug company applied for emergency use authorization in October after it said that research suggested the antibody treatment could help keep coronavirus patients from reaching the point of hospitalization.

The FDA’s authorization “provides health care professionals on the frontline of this pandemic with another potential tool in treating Covid-19 [coronavirus] patients,” Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

Bamlanivimab is similar to Regeneron’s experimental antibody cocktail, which President Donald Trump took while he was hospitalized for the coronavirus at Walter Reed National Military Medical Center.

However, the FDA states that the emergency use authorization does not apply to already hospitalized patients or for people who have trouble breathing.

Bamlanivimab is given intravenously in a single dose. In safety studies of approximately 800 people, the drug led to a severe allergic reaction in one person who needed epinephrine to stop it.

The FDA said other side effects of the drug include dizziness, nausea, diarrhea, itching, headache, and vomiting.

Eli Lilly has already begun manufacturing the drug and said it expects to have one million doses ready by the end of the year.



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