Regeneron Pharmaceuticals Inc.'s antibody cocktail received an emergency use authorization from USA drug regulators for treatment of early COVID-19 symptoms, adding to the expanding arsenal of therapies available to physicians.
Unlike some other drugs used for Covid-19, the antibody cocktail is meant to be given early in infection, before patients are hospitalized or require oxygen therapy. 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.
In September, Regeneron announced it is to create an additional 400 jobs in Limerick to allow it to maximise manufacturing capacity at its NY facility for its Covid-19 antibody drug combination REGN-COV2. This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors, say Regeneron.
The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to moderate Covid-19 in adults and paediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe Covid-19.
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"This FDA Emergency Use Authorisation is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection", said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.
This compared to nine percent in placebo-treated patients. Patients with other conditions like diabetes, cardiovascular disease or chronic kidney disease also qualify for the drug.
"Regeneron now expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021", the company said in a news release Saturday. The report noted that more than 360,000 cases have been added in the last two days only.
Regeneron has received more than $450 million from the USA government for its Covid-19 drug development efforts under Operation Warp Speed. To win full approval, Regeneron will have to submit additional research to fully define the drugs safety and benefit for patients.
They then harvested the immune cells that made those antibodies and grew them in a lab, in order to create a mass treatment.