The Covid-19 therapy used on President Donald Trump was approved by the US drug regulator for people who aren’t yet hospitalized by the disease but are at high risk.
The green light for drugmaker Regeneron came after REGEN-COV2, a combination of two lab-made antibodies, was shown to reduce Covid-19-related hospitalizations or emergency room visits in patients with underlying conditions.
“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said Stephen Hahn, commissioner of the Food and Drug Administration (FDA).
Leonard Schleifer, Regeneron’s president and CEO, added the move was “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.”
Regeneron’s antibody treatment is the second synthetic antibody treatment to receive an emergency use approval (EUA) from the FDA after a similar therapy developed by Eli Lilly was granted the status on November 9.
The human immune system naturally develops infection-fighting proteins called antibodies — but because not everyone mounts an adequate response, companies like Regeneron and Lilly have manufactured lab-made solutions.
They work by binding to a surface protein of the SARS-CoV-2 virus and stopping it from invading human cells.
The FDA said the data supporting Regeneron’s EUA came from a clinical trial in 799 non-hospitalized patients with mild to moderate symptoms of 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.
This compared to nine percent in placebo-treated patients.
Patients treated with the drug also had lower levels of virus remaining compared to those on the placebo.