FDA authorizes Eli Lilly's Covid-19 antibody treatment for emergency use
Source: NBC News
The Food and Drug Administration has granted an emergency use authorization for Eli Lilly's Covid-19 monoclonal antibody treatment, called bamlanivimab.
The FDA action specifies that the therapy is meant for adults and children over age 12 with mild to moderate illness but who have high risks of getting much worse and needing hospitalization. That includes people with underlying health conditions, such as diabetes, sickle cell disease, chronic kidney disease or obesity, or anyone over age 65. The move vastly expands doctors' ability to use Eli Lilly's monoclonal antibody treatment. Previously, physicians were limited to trying the drug in clinical trials...
The FDA said the decision was based on interim analysis from a phase 2 clinical trial in 465 adults with mild to moderate Covid-19 symptoms. The research suggested that the drug was no better than a placebo in helping patients clear the virus from their bodies; however, it did reduce the likelihood that patients would later need to be hospitalized.
Bamlanivimab is given through an IV in a single dose. In safety studies of about 800 people, the drug led to a severe allergic reaction in one person who needed an emergency medication called epinephrine to stop the reaction. The FDA said other possible side effects of bamlanivimab include nausea, diarrhea, dizziness, headache, itching and vomiting.
Read more: https://www.nbcnews.com/health/health-news/fda-authorizes-eli-lilly-s-covid-19-antibody-treatment-emergency-n1247201
= new reply since forum marked as read
