FDA authorizes Eli Lilly antibody treatment for high-risk young children.

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The Food and Drug Administration on Friday approved Eli Lilly’s monoclonal antibody treatment for infants and children under 12 with Covid-19 who are at high risk of becoming seriously ill from the virus because they have a condition such as obesity or diabetes.

Previously, high-risk Covid patients aged 12 years or older were eligible for the drugs, which are typically given intravenously in a clinic or hospital and have been shown to lower the risk of hospitalization and death.

Until now, “we had nothing for young children” with Covid that could keep them out of the hospital, said Dr. Walid F. Gellad, director of the Center for Pharmaceutical Policy and Prescribe at the University of Pittsburgh’s Faculty of Medicine.

The authorization comes as fears mount over a winter wave fueled by the new Omicron coronavirus variant, which appears to be spreading due to a mix of its infectiousness and its ability to evade the body’s immune defenses. It is not yet known how Omicron may affect young children compared to other versions of the virus, or whether Lilly’s antibody treatment may be less effective against it.

Hospital admissions of children with Covid rose over the summer amid a spate of Delta cases. Of the states reporting the data, between 0.1 percent and 1.9 percent of all confirmed cases of Covid in children have resulted in hospitalization, according to the American Academy of Pediatrics.

The FDA said body weight-adjusted doses of Lilly’s treatment, a cocktail of two antibody drugs, were being studied in a safety study involving 125 pediatric patients.

“Parents of young children, especially young children at high risk, have had a hard time because although their children are at lower risk, the focus was not on that age, until recently with the vaccinations,” said Dr. Gellad. “It’s always good to have another option, but it’s always worth reiterating that vaccination is not a substitute.”

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