Eli Lilly’s Monoclonal Antibody Gets FDA Emergency Use Authorization

The FDA has issued an Emergency Use Authorization (EUA) for Eli Lilly’s monoclonal antibody treatment bamlanivimab (LY-CoV555), clearing the drug for use in high-risk patients with mild-to-moderate COVID-19 who don’t need hospitalization or oxygen.

The emergency clearance, the first for a COVID-19 antibody, was granted Monday evening based on data from the drugmaker’s 800-participant phase 2 study of nonhospitalized, high-risk patients recently diagnosed with mild-to-moderate coronavirus. The treatment reduced viral loads, rates of symptoms and hospitalizations, the company said, citing an interim analysis.

Now that it has obtained an EUA, Eli Lilly said it will immediately start shipping supplies of the treatment to AmerisourceBergen for distribution under the U.S. government’s allocation program. The government has secured 300,000 vials of the experimental antibody that it will give to high-risk patients for free.

 “The data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” said Daniel Skovronsky, chief scientific officer for Eli Lilly and president of Lilly Research Laboratories.

The emergency authorization — which the company applied for a month ago (DID, Oct. 8) — allows the drug to be distributed and administered as a single intravenous dose by healthcare providers. The EUA is for patients 12 and older who weigh at least 88 pounds, including patients 65 and above and those with certain chronic medical conditions. It is accompanied by a warning for hypersensitivity, including anaphylaxis and infusion-related reactions, the company noted.

“While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was 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, noting that its EUA does not extend to patients who are hospitalized or require oxygen therapy due to coronavirus infection. — James Miessler