Emergency use of antibody received by President Trump approved by FDA
A.P – U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month.
The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms.
The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.
Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said.