Covid-19 antibody drugs can now be used to treat pediatric patients, including newborns. FDA has Expand emergency authorization Eli Lilly drugs to include younger age groups.
Eli Lilly’s drug, it matches Two antibodies, bamlanivimab and etesevimab, were initially approved in February for patients 12 years of age and older They have tested positive for the new coronavirus and are very likely to develop a serious illness that may lead to hospitalization and death. This authorization covers people weighing at least 40 kg (approximately 88 pounds).
This is the second time the emergency authorization for infusion therapy has been modified. In September, the FDA Expansion of authorized use Including the prevention of Covid-19 infection in people who have been exposed to the new coronavirus and who have not been fully vaccinated or have a compromised immune system that does not produce an adequate immune response to the vaccine. The expansion of the authorization on Friday covers the treatment of young children with confirmed infections and the prevention of those who have been exposed to Covid-19.
The FDA’s latest action is based on the results of a Phase 2/3 clinical trial that enrolled 125 pediatric patients, all of whom had at least one serious Covid-19 risk factor. For patients weighing less than 88 pounds, the dosage is adjusted according to the patient’s weight to achieve the level of the drug in the body equivalent to the authorized dosage for adults and adolescents. A total of 14 patients took the placebo.
The results of the test showed that patients weighing 88 pounds or more received an authorized dose of Eli Lilly and their symptoms were relieved at a median time of 7 days. For clinical trial participants whose dose is determined by body weight, the median time to resolution of symptoms is five days. The youngest participant in the pediatric clinical trial was only 10 months old and weighed about 18 pounds.
The FDA stated that the safety of Eli Lilly’s antibody cocktail in pediatric trials is comparable to that reported in adult and adolescent drug research reports. There were no reports of death or hospitalization in the young group.
“Now, all high-risk patients with severe COVID-19, including children and newborns, have options for treatment and post-exposure prevention,” said Patrizia Cavazzoni, director of the FDA Children’s Drug Evaluation and Research Center ( Patrizia Cavazzoni) said in a statement. Prepared statement“Children under the age of 1 who are exposed to the virus that causes COVID-19 are at a particularly high risk of severe COVID-19. This authorization addresses the medical needs of this vulnerable group.”
Cavazzoni added that although the expanded authorization covers the prevention of Covid-19 in children, the drug is not a substitute for vaccination. The Pfizer/BioNTech vaccine is the only vaccine authorized for use in children, a decision made in late October, covering children between 5 and 11 years of age.
The antibodies that make up Eli Lilly’s drugs are proteins designed in the laboratory to target the spike protein of SARS-CoV-2, blocking its ability to attach and enter human cells. The use of two antibodies can reduce the chance of the virus becoming resistant to the treatment. Although bamlanivimab and etesevimab both target spike proteins, the FDA stated that they bind to different but overlapping locations on the protein.
Eli Lilly has tested its antibody drug against the new coronavirus delta variant, which has become the dominant strain. According to the company, the drug cocktail continues to neutralize this variant. Before the discovery of the omicron variant, clinical trials for young pediatric patients began.Lily said in an article statement It “is quickly learning about the neutralizing activity of our therapy on the omicron variant of interest.”
Regeneron Pharmaceuticals also owns an antibody drug REGEN-COV, which consists of two monoclonal antibodies.The company stated earlier this week that previous laboratory tests and structural models of mutations present in omicron indicated May reduce neutralization Antibodies produced by vaccines and antibodies containing antibody drugs, such as REGEN-COV. Regeneron has other antibody drugs in clinical development. The biotech company said that preliminary analysis suggests that some of them may have the potential to fight omicron variants and worrying variants. Expect more laboratory data next month.
Another antibody drug authorized by the FDA comes from Vir Biotechnology and GlaxoSmithKline. The drug sotrivimab is a monoclonal antibody, not a cocktail. But the drug is designed to address a conserved spike protein region-even if the virus mutates, it will not change much. This means that the drug has a better chance of continuing to fight new variants. GSK and Vir stated that their preclinical data to date shows that their drugs Keep alive For all tested variants of interest, including omicron.
Photo: metinkiyak, Getty Images
