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The green light was lit for the pharmaceutical company after its drug REGEN-COV2, a combination of two laboratory-produced antibodies, was found to reduce the number of COVID-19 hospitalizations or admissions among patients with comorbidities.
“Prescribing these monoclonal antibody drugs can help outpatients avoid hospitalization and ease the burden on our health care system,” said Stephen Hahn, director of the US Food and Drug Administration (FDA).
Leonard Schleifer, President and CEO of Regeneron, added that this decision “is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to promising treatments early in their disease. “.
Regeneron is the second synthetic antibody drug to receive immediate FDA approval. A similar drug manufactured by Eli Lilly was approved on November 9.
The human immune system naturally produces infection-fighting proteins called antibodies. However, not everyone gets an adequate answer, which is why companies like Regeneron and Eli Lilly offer lab-developed solutions.
These drugs work by binding to the surface protein of the SARS-CoV-2 virus and preventing the virus from infecting human cells.
The FDA reports that the evidence for Regeneron’s effectiveness came from a clinical study in 799 outpatients who had mild symptoms of COVID-19. Among high-risk patients with comorbid conditions ranging from obesity to age and diabetes, hospitalization and hospital admissions required three percent of patients who received the drug intravenously.
In comparison, in the group that received placebo, the proportion was 9 percent.
Regeneron says he expects to have doses in 80,000 patients by the end of November and about 300,000 by the end of January. patients.
Regeneron has received more than $ 450 million from the United States government for the development of COVID-19. AMERICAN DOLLAR.
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