FDA approves monoclonal antibody therapy for newborns – Lexington-Fayette, Kentucky

Lexington-Fayette, Kentucky 2021-12-03 17:36:14 –

Newborn and young pediatric patients who test positive for COVID-19 can receive monoclonal antibody therapy previously approved for ages 12 and older.

The Food and Drug Administration announced on Friday that it has revised its emergency use authorization for gamlanivimab and etesebimab.

According to the FDA, monoclonal antibodies are used to treat mild to moderate COVID-19 in all young pediatric patients, including newborns who are positive for COVID-19 testing and are at high risk of progressing to severe COVID-19. You can now do it, including hospitalization and death. “

The FDA warns that this treatment is not a substitute for vaccination.

“Vaccines are still the best tool in the fight against the virus, and there is a COVID-19 vaccine approved for children over the age of 5,” said Dr. Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research.

The FDA says it has expanded its emergency use authorization following clinical trials in 125 pediatric patients who have shown that monoclonal antibodies are safe and effective.

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