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The emergency authorization was granted to the pharmaceutical company Regeneron on Saturday.
This means that a cocktail of two antibodies, kasirivimab and imdevimab, can be used to treat people over 12 years of age with mild to moderate COVID-19 who are at risk of complications.
This treatment should not be used in coronavirus-infected patients who are hospitalized or require supplemental oxygen.
According to the FDA, the green light comes on urgently, based on an assessment of the potential benefits and risks of treatment in emergency situations. It is emphasized that FDA approval does not imply approval.
The FDA granted approval after a clinical study of nearly 800 adult patients treated out of hospital. These subjects experienced mild to moderate symptoms of COVID-19.
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