Regeneron Pharmaceuticals Inc.'s antibody cocktail received an emergency use authorization from us drug regulators for treatment of early COVID-19 symptoms, adding to the expanding arsenal of therapies available to physicians.
Regeneron said it will have enough of the treatment for 80,000 patients by the end of November. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19.
The FDA said the antibodies are not authorised for patients who are hospitalised due to Covid-19 or require oxygen therapy due to Covid-19.
For patients who were at high risk because of a variety of underlying conditions - from obesity to old age to diabetes - hospitalization and emergency room visits occurred in three percent of patients who received the intravenous treatment.
The antibody cocktail of casirivimab and imdevimab administered together (also known as REGEN-COV2) can now be used for patients at high risk for progressing to severe COVID-19 and/or hospitalization.
Regeneron is set to have doses ready for 80,000 patients by the end of this month and come January 2021, around 3 lakh patients can be given doses for these.
Initial supplies will likely be vastly outstripped by demand as the USA has surged past 10 million reported cases, with the country facing what health experts say will be a dark winter due uncontrolled spread of the virus. With two antibodies, the hope is to trap and shut down viral replication.
An emergency use authorization (EUA) is a lower regulatory bar than full approval by the FDA.
"The FDA remains committed to advancing the nation's public health during this unprecedented pandemic". According to news agency AFP citing Stephen Hahn, commissioner of the Food and Drug Administration (FDA), the authorisation of such therapy will help in reducing the burden on US's healthcare system the number of patients taken to hospitals will reduce.
"The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated".