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The Food and Drug Administration has granted emergency use authorization for treatment with Eli Lilly’s Covid-19 monoclonal antibody, called bamlanivimab.
The FDA action says the therapy is for adults and children over 12 with mild to moderate illness, but who are at high risk of getting worse and requiring hospitalization. This includes people with underlying health conditions, such as diabetes, sickle cell disease, chronic kidney disease, or obesity, or anyone over the age of 65.
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The move significantly expands doctors’ ability to use Eli Lilly’s monoclonal antibody therapy. Previously, doctors were limited to trying the drug in clinical trials.
Eli Lilly applied for emergency use authorization in early October after the company said research suggested the therapy could help prevent Covid-19 patients from progressing to where they should be hospitalized.
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The action “provides healthcare professionals on the front lines of this pandemic with another potential tool in the treatment of patients with Covid-19,” said Dr Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research at the FDA, in a statement.
Bamlanivimab is similar to one of the treatments President Donald Trump received when he was hospitalized for Covid-19. However, the FDA has stipulated that this emergency use authorization does not apply to patients who are in hospital or who need assistance with breathing. Regulators have said these patients may, indeed, do worse if they are hospitalized due to a need for high-flow oxygen or mechanical ventilation.
Monoclonal antibodies are made in a laboratory to mimic the body’s natural antibodies. Antibodies work by recognizing specific pathogens – in this case, SARS-CoV-2, the virus that causes Covid-19 – and harnessing the immune system to fight them.
The FDA said the decision was based on an interim analysis of a Phase 2 clinical trial in 465 adults with mild to moderate Covid-19 symptoms. Research suggested the drug was no better than a placebo at helping patients clear the virus from their bodies; however, this reduced the likelihood that patients would later need to be hospitalized.
Bamlanivimab is administered intravenously as a single dose. In safety studies involving around 800 people, the drug caused a severe allergic reaction in a person who needed an emergency drug called epinephrine to stop the reaction.
The FDA has stated that other possible side effects of bamlanivimab include nausea, diarrhea, dizziness, headache, itching, and vomiting.
Eli Lilly has already started manufacturing the drug, and he said he could have up to 1 million doses available by the end of the year.
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