Pharma, BioPharma

Infants, kids now have a Covid-19 therapy as FDA expands use of Eli Lilly drug

Eli Lilly’s authorized antibody drug for treating and preventing Covid-19 infection in adolescents and adults is now authorized for pediatric patients, including newborns. While tests are still assessing whether the drug works against omicron, early data suggest a Vir Biotechnology antibody can address the new variant but Regeneron Pharmaceuticals’ antibody drug might not.

 

Pediatric patients, including newborns, can now be treated with an antibody drug for Covid-19. The FDA has expanded the emergency authorization of an Eli Lilly drug to include the younger age group.

Lilly’s drug, which pairs the two antibodies bamlanivimab and etesevimab, was initially authorized in February for patients 12 and older who tested positive for the novel coronavirus and are at high risk of progressing to severe disease that could lead to hospitalization and death. That authorization covered those weighing at least 40 kilograms (about 88 pounds).

It’s the second time that emergency authorization has been amended for the infused therapy. In September, the FDA expanded authorized use to include preventing Covid-19 infection in those who have been exposed to the novel coronavirus and either are not fully vaccinated or are not expected to mount an adequate immune response to a vaccine due to a compromised immune system. Friday’s expansion to the authorization covers treatment of younger children with a confirmed infection, as well prevention of Covid-19 in those who have been exposed to it.

The FDA based its latest action on the results of a Phase 2/3 clinical trial that enrolled 125 pediatric patients, all of whom had at least one risk factor for severe Covid-19. For those who were less than 88 pounds, the dose was adjusted according to patient weight in order to achieve drug levels in the body comparable to what was reached with the authorized dose in adults and adolescents. A total of 14 patients were given a placebo.

The trial results showed that patients 88 pounds or greater who received the Lilly drug at the already authorized dose achieved symptom resolution in a median time of seven days. For clinical trial participants whose dose was determined by their weight, the median time to symptom resolution was five days. The youngest participant in the pediatric clinical trial was 10 months of age and weighed about 18 pounds.

The FDA said that the safety of the Lilly antibody cocktail in the pediatric trial was comparable to what was reported in studies of the drug in adults and adolescents. No deaths or hospitalizations were reported in the younger group.

“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research Children said in a prepared statement. “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 authorization addresses the medical needs of this vulnerable population.”

Cavazzoni added that even though the expanded authorization covers prevention of Covid-19 in children, the drug is not a substitute for vaccination. The Pfizer/BioNTech vaccine is the only one that is authorized for children, a late October decision that covers kids age 5 to 11.

The antibodies that comprise the Lilly drug are proteins engineered in a lab to target the spike protein of SARS-CoV-2, blocking its ability to attach to and enter human cells. Using two antibodies reduces the chances that the virus develops resistance to the therapy. While both bamlanivimab and etesevimab target the spike protein, the FDA said that they bind to different but overlapping places on that protein.

Lilly has conducted tests of its antibody drug against the novel coronavirus’s delta variant, which has become the predominant strain. According to the company, the drug cocktail continues to be able to neutralize that variant. The clinical trial in younger pediatric patients began before the omicron variant was identified. Lilly said in a statement that it is “working quickly to understand neutralization activity of our therapies on the omicron variant of concern.”

Regeneron Pharmaceuticals also has an antibody drug, REGEN-COV, comprised of two monoclonal antibodies. The company said earlier in the week that prior lab testing and structural modeling of mutations present in omicron indicate that there may be reduced neutralization to antibodies produced by vaccines as well as the antibodies that comprise antibody drugs, such as REGEN-COV. Regeneron has additional antibody drugs in clinical development. The biotech said that preliminary analyses suggest that several of them may have the potential to work against the omicron variant, as well as variants of concern. More lab data are expected in the coming month.

The other FDA-authorized antibody drug is from Vir Biotechnology and GlaxoSmithKline. That drug, sotrivimab, is a monoclonal antibody, not a cocktail. But the drug is designed to address a region of the spike protein that’s conserved—it does not change much even as the virus mutates. That means the drug has a better chance of continuing to work against new variants. GSK and Vir said that their preclinical data so far show that their drug retains activity against all of the tested variants of concern, including omicron.

Photo: metinkiyak, Getty images

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