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FDA authorizes REGEN-COV for post-exposure prophylaxis (prevention) for COVID-19

August 10, 2021

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and youth 12 years of age and older who are at high risk for progression to severe COVID-19, including hospitalization or death.

REGEN-COV is not a substitute for vaccination against COVID-19. Vaccination against COVID-19 continues to be the most effective method to prevent serious illness and decrease the spread of COVID-19.

REGEN-COV should only be used as post-exposure prophylaxis for individuals who are:
  • not fully vaccinated or who are not expected to mount an adequate immune response to COVID-19 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and
    • have been exposed to an individual infected with COVID-19 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or
    • who are at high risk of exposure to an individual infected with COVID-19 because of occurrence of COVID-19 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)
REGEN-COV is safe to use with MS disease modifying therapies (DMTs) but the timing might need to be coordinated. People should talk to their MS health care provider about whether the use of REGEN-COV for post-exposure prophylaxis is appropriate for them and how to time it safely with their DMT.
 

En Español:

FDA autoriza REGEN-COV como profilaxis posterior a la exposición (prevención) del COVID-19

10 de Agosto del 2021

La Dirección de Alimentos y Medicamentos de Estados Unidos (U.S. Food and Drug Administration o FDA) ha autorizado el uso de emergencia de REGEN-COV (casirivimab e imdevimab, administrados juntos) para el uso de emergencia como profilaxis posterior a la exposición (prevención) para el COVID-19 en adultos y jóvenes mayores de 12 que tienen alto riesgo de progresión a COVID-19 grave, lo que incluye la hospitalización o muerte.

REGEN-COV no es un sustituto a la vacunación contra el COVID-19. La vacunación contra el COVID-19 sigue siendo el método más eficaz para prevenir la enfermedad y disminuir el contagio del COVID-19.

REGEN-COV solo se debe usar como profilaxis posterior a la exposición en personas que:
  • no están totalmente vacunadas o no se tiene previsto que tengan una respuesta inmunitaria adecuada a la vacunación contra el COVID-19 (por ejemplo, personas con enfermedades inmunodepresoras, incluidas aquellas que toman medicamentos inmunodepresores), y
    • han estado expuestas a una persona infectada con el COVID-19 bajo los criterios de contacto cercano de los Centros de Control y Prevención de Enfermedades (Centers for Disease Control and Prevention o CDC) o
    • tienen alto riesgo de exposición a una persona infectada con COVID-19 debido a un caso de infección con COVID-19 en otras personas en el mismo entorno institucional (por ejemplo, hogar de reposo o prisión)
Las personas con esclerosis múltiple que toman ciertos medicamentos modificadores de la enfermedad deben consultar con su profesional de salud si es apropiado en su caso usar REGEN-COV como profilaxis posterior a la exposición.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.

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