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FDA Expands Authorization For Lilly’s COVID-19 Antibody Therapy To Include Young Children & Infants

(RTTNews) – The United States Food and Drug Administration expanded the emergency use authorization for etesevimab (JS016/LY-CoV016) and bamlanivimab (LY-CoV555) administered together to include certain high-risk pediatric patients from birth to under 12 years old for the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis, Junshi Biosciences and its global partner Eli Lilly and Co. (LLY) said in a statement.

According to the companies, the therapy has been the first and only authorized neutralizing antibody therapy for emergency use in COVID-19 individuals under the age of 12 and offers treatment and prevention options to high-risk individuals of any age.

In February 2021, the therapy was granted emergency use authorization by the FDA for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.

In September 2021, the therapy was granted emergency use authorization for post-exposure prophylaxis in high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison.

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