The
U.S. Food and Drug Administration (Fda) has expanded the emergency use authorization for bamlanivimab and etesevimab antibodies given together for patients under 12 years of age.
This was
announced by
the Eli Lilly company on its website,
underlining that "this expansion allows bamlanivimab and etesevimab to be administered together in pediatric patients at high risk for the treatment of Covid-19 and for post-exposure prophylaxis".
It is the first authorized antibody treatment for children and infants, the company reports.
"No pediatric subjects have died or required hospitalization due to Covid-19," the company reports. "With the FDA's decision to allow the use of bamlanivimab with etesevimab in children and infants, Lilly can now offer treatment and prevention options to high-risk individuals of any age," said Daniel Skovronsky, MD, Ph.D ., Lilly's chief scientific and medical officer and president of Lilly Research Laboratories. Bamlanivimab and etesevimab, when administered together - reports the company - maintain the neutralization activity against the Delta variant and "Lilly is working quickly to understand the neutralization activity of our therapies on the Omicron variant", he said.With respect to the results of the phase 2/3 clinical trial in neonates and pediatric patients, the median time to complete resolution of symptoms was 7 days for subjects treated with bamlanivimab 700mg and etesevimab 1,400mg and 5 days for subjects treated with weight-based dosing of bamlanivimab and etesevimab.
Overall, more than 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab to date, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst period of the pandemic, the company says. Bamlanivimab is a recombinant and neutralizing human IgG1 monoclonal antibody (mAb) directed against the SARS-CoV-2 spike protein. It was designed to block viral attack and entry into human cells, thereby neutralizing the virus. Emerging from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of Covid-19, Bamlanivimab was identified from a blood sample taken from one of the first US patients recovered from Covid-19. Etesevimab (LY-CoV016,also known as JS016) is a neutralizing fully human recombinant monoclonal antibody, which binds specifically to the Sars-CoV-2 surface spike protein receptor binding domain with high affinity and can block virus binding to the surface receptor of the host cell ACE2 host cell surface receptor.
