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.
The authorization covers children who are at high risk of becoming seriously ill with the virus because they have a condition such as obesity or diabetes. “So far we didn’t have something for young children,” with Covid, kn able to keep them out of the hospital, said Dr. Walid F. Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University’s School of Medicine. Pittsburgh. “Parents of young children, especially those at high risk, have had a difficult time because even though their children are at low risk, the focus has not been at that age, until recently with vaccinations” said Dr. Gellad. “It is always good to have another option, but it is always worth reiterating that it does not replace vaccination.”
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.