The expanded EUA was based on safety and efficacy data of paediatric and infant patients in Phase 2/3 BLAZE-1 trial, in Covid-19 patients who are at high-risk for severe disease
Bamlanivimab and etesevimab are monoclonal antibodies. (Credit: Cassiopeia_Arts from Pixabay.)
The US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for bamlanivimab plus etesevimab, Lilly’s monoclonal antibody therapies for Covid-19 treatment.
The EUA expands the regimen’s indication to include mild to moderate Covid-19 in high-risk paediatric patients, aged below 12 years, along with post-exposure prophylaxis.
In February this year, the US agency initially authorised the regimen to treat mild to moderate Covid-19 in at-risk adults and children, aged 12 years and above.
In September, the combination was authorised for the post-exposure prevention of Covid-19 in certain adults and children, aged 12 years and above, who are at high risk of severe disease.
FDA Centre for Drug Evaluation and Research director Patrizia Cavazzoni said: “Now all patients at high risk of severe Covid-19, including children and newborn babies, have an option for treatment and post-exposure prevention.
“Children under one year of age who are exposed to the virus that causes Covid-19 may be at particularly high risk for severe Covid-19 and this authorisation addresses the medical needs of this vulnerable population.
“While today’s authorisation includes post-exposure prevention of Covid-19 in children, this therapeutic option is not a substitute for vaccination. Vaccines remain our best tool in the fight against the virus and there is a Covid-19 vaccine authorized for children five years of age and above.”
Bamlanivimab and etesevimab are two monoclonal antibodies and are administered together through intravenous infusion, to treat people with Covid-19.
The expanded EUA was based on safety and efficacy data of paediatric and infant patients in Phase 2/3 BLAZE-1 trial, in Covid-19 patients who are at high-risk for severe disease.
In the study, bamlanivimab 700mg and etesevimab 1,400mg achieved a complete symptom resolution in a median time of seven days and five days, respectively.
Lilly claimed that bamlanivimab and etesevimab combination would retain the neutralisation activity against the Delta variant, a variant of concern in the US.
The company has conducted pseudovirus and authentic virus studies to confirm the activity of bamlanivimab and etesevimab against the Delta variant.
Furthermore, Lilly is working to determine the activity of its therapeutics on neutralising the new Omicron variant, declared as a Variant of Concern by WHO.
Lilly chief scientific and medical officer Daniel Skovronsky said: “Our mission since the start of the pandemic has been to offer crucial support by developing therapeutic options that could prevent hospitalization and death for as many people as possible.
“With the FDA’s decision to allow use of bamlanivimab with etesevimab in children and infants, Lilly can now offer treatment and prevention options to high-risk individuals of any age.”