US FDA issues emergency use authorisation to first COVID-19 antibody drug

The United States Food and Drug Administration (FDA) on November 9 issued an emergency use authorization (EUA) for investigational antibody therapy in patients with mild and moderate COVID-19. The experimental antibody therapy bamlanivimab has been authorised for patients who are 12 years of age and older and are at high risk of progressing to severe COVID-19. 

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Safety & effectiveness not proven yet

The FDA informed that the safety and effectiveness of bamlanivimab is still under evaluation but added that the drug showed positive results during clinical trials as it reduced COVID-19-related hospitalisation in patients with a high risk of progressing to severe stage. The FDA said that bamlanivimab is not authorised in patients who are hospitalised are under oxygen support. 

"As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective," said FDA Commissioner Stephen M. Hahn, M.D. in a statement. 

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Bamlanivimab is a monoclonal antibody therapy that is specifically designed to fight against the spike protein of SARS-CoV-2. Monoclonal antibodies are laboratory-made proteins that mimic the way our immune system responds to viruses and then fights it off. Antibody therapy has been developed by  Eli Lilly & Company. 

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"The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers. The EUA requires that fact sheets that provide important information about using bamlanivimab in treating COVID-19 be made available to health care providers and to patients and caregivers, including dosing instructions, potential side effects, and drug interactions", FDA said in a statement. 

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