Regeneron’s REGEN-COV2 first antibody cocktail for COVID-19 to receive FDA emergency use authorization

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TARRYTOWN, N.Y.—- Regeneron Pharmaceuticals, Inc. has received Emergency Use Authorization for REGEN-COV2 from the U.S. Food and Drug Administration (FDA). This is the first treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2.

REGEN-COV2 is authorized for recently diagnosed, mild to moderate COVID-19 in high-risk patients.

Definition of High-Risk Patients

High-risk is defined as patients who meet at least one of the following criteria:

  • Have a body mass index (BMI) ≥ 35
  • Have chronic kidney disease
  • Have diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are ≥ 65 years of age
  • Are ≥ 55 years of age AND have
    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory diseases.
  • Are 12 – 17 years of age AND have
    • BMI ≥ 85th percentile for their age and gender-based on CDC growth charts, OR
    • sickle cell disease, OR
    • congenital or acquired heart disease, OR
    • neurodevelopmental disorders, for example, cerebral palsy, OR
    • a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
    • asthma, reactive airway, or other chronic respiratory diseases that require daily medication for control.

Those treatment doses will be 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, with no medication out-of-pocket costs, under the U.S. government allocation program.

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