FDA Grants EUA to Lilly's Antibody Treatment Bamlanivimab for COVID-19
Bamlanivimab should be administered as soon as possible after a positive test, and within 10 days of developing symptoms, Eli Lilly said.
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Eli Lilly for bamlanivimab (LY-CoV555), the company's investigational neutralizing antibody for the treatment of coronavirus disease 2019 (COVID-19).
Bamlanivimab is intended to treat adults and pediatric patients 12 years and older who have been recently diagnosed with mild to moderate COVID-19 and who are considered high-risk for developing severe infection that may require hospitalization, according to the company.
Delivered as a single, intravenous, 700-mg infusion, bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
The FDA's decision to grant an EUA is based on results from the randomized, double-blind, placebo-controlled phase 2 BLAZE-1 study, in which the treatment led to reduced viral loads and reduced rates of symptom progression and hospitalization in patents with mild to moderate COVID-19 in the outpatient setting.
"The BLAZE-1 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," Lilly's chief scientific officer and president of Lilly Research Laboratories Daniel Skovronsky, MD, PhD, said in a statement.
The FDA included a warning for hypersensitivity, including anaphylaxis and infusion-related reactions, with its EUA. In BLAZE-1, adverse events were similar between the study and placebo arms, and were considered mild to moderate in severity.
Notably, bamlanivimab could be particularly beneficial for patients aged 65 years of age and older, with certain chronic comorbid medical conditions. According to the BLAZE-1 interim analysis, nearly three-quarters of the patients were found to have at least 1 risk factor for severe illness, including age of 65 years or older, a body mass index of 35 or more, or at least one relevant coexisting illness.
Lilly plans to begin distribution immediately after striking a $375 million deal last month with the United States government for 300,000 doses of the treatment.