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    Sprint Use for antibody treatments, but Maw cautious

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November 10, 2020 The US Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for the neutralizing antibody Bamlanivimab (LY-CoV555) manufactured by Eli Lilly.

The use of Bamlanivimab is authorized for the treatment of mild to moderate cases of Covid-19 in adult and pediatric patients who are at least 12 years old and who have tested positive and who are at high risk of progression to severe or hospitalization.

Bamlanivimab should be administered as soon as possible and within 10 days of the onset of symptoms.

The authorization allows for the distribution and emergency use of Bamlanivimab, which is administered as a single intravenous infusion.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight harmful antigens such as viruses.



Bamlanivimab is a monoclonal antibody specifically directed against the SARS-CoV-2 spike protein, designed to block virus aggression and entry into human cells.

"This emergency clearance allows us to make Bamlanivimab available as a Covid-19 treatment for newly diagnosed high-risk patients, adding a valuable tool for clinicians battling this global pandemic," said David A. Ricks, president and chief executive officer. by Lilly.

The grant is based on data from BLAZE-1, a randomized, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 on an outpatient basis.

Patients treated with Bamlanivimab showed reduced viral load.

In the BLAZE-1 study, the frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority of mild to moderate severity.

Infusion reactions and other allergic hypersensitivity events have been reported.