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.
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.
Trial findings released by Regeneron in October showed the drug may help treat patients outside the hospital, reducing virus levels and the need for further medical care.
The treatment is by USA biotech company Regeneron Pharmaceuticals Inc. and uses casirivimab and imdevimab to be administered together.
The FDA's authorization is limited to high-risk patients, like those who are older than 65 years of age or have a BMI greater than or equal to 35.
This compared to nine percent in placebo-treated patients.
Initial supplies will likely be vastly outstripped by demand as the US 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.
The recommended dose is 1,200 milligrams of each of the two antibodies, for a total of 2,400 milligrams, in a single infusion. 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 U.S. government for its Covid-19 drug development efforts under Operation Warp Speed.
Earlier this month, the FDA issued an emergency use authorization for another antibody treatment from pharmaceutical manufacturer Eli Lilly with similar conditions.
An emergency use authorization (EUA) is a lower regulatory bar than full approval by the FDA.
Covid-19 vaccines, like those developed by Pfizer and Moderna, work by training the immune system to make its own antibodies so they are prepared when they encounter the virus.