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COVID-19 Antibody Therapy Now Available For Treatment and Post-Exposure Prophylaxis

August 4, 2021 • 12:50 pm CDT
(Precision Vaccinations News)

New York-based Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV™.

The FDA's EUA now includes post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 coronavirus infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).

Additionally, for those who require repeat dosing for ongoing exposure, REGEN-COV can also now be administered monthly.

This new indication in people aged 12 and older is in addition to the previously granted EUA to treat non-hospitalized patients.

"Today's FDA authorization enables certain people at high risk of developing severe COVID-19 infection to access REGEN-COV if they have been exposed to the virus – the first time an antibody treatment has been authorized for this purpose," stated George D. Yancopoulos, M.D., Ph.D., President and CEO of Regeneron, in a press statement issued on July 30, 2021.

"With this authorization, the FDA specifically highlights the needs of immunocompromised people, including those taking immunosuppressive medicines, who may not mount an adequate response to (COVID-19) vaccination."

And "who are exposed to a person with COVID-19 or are in an institutional setting and are at high risk of exposure because of infection occurring in the same setting."

The "FDA decision to expand the use of REGEN-COV in post-exposure settings is a very helpful step, and we continue to work with the FDA as it undertakes its review of REGEN-COV in a broader group of people including in a pre-exposure prophylactic setting for people who are immunocompromised, and in patients hospitalized due to COVID-19."

Experts estimate that approximately 3% of the U.S. population may not respond fully to COVID-19 vaccination because of immunocompromising conditions or immunosuppressive medicines.

This group includes people receiving chemotherapy, people with hematologic cancers such as chronic lymphocytic leukemia, people receiving stem cells or hemodialysis, people who have received organ transplants, and/or people taking certain medications that might blunt immune response (e.g., mycophenolate, rituximab, azathioprine, anti-CD20 monoclonal antibodies, Bruton tyrosine kinase inhibitors).

This new FDA EUA enables these groups to use REGEN-COV to prevent infection in post-exposure and certain institutional settings.

Under the EUA for post-exposure prophylaxis, REGEN-COV can be administered by subcutaneous injection or intravenous infusion.

For people who aren't expected to mount an adequate immune response to vaccination and have ongoing exposure to SARS-CoV-2 for more than four weeks, the initial 1,200 mg dose can be followed by subsequent repeat dosing of REGEN-COV 600 mg once every four weeks, for the duration of ongoing exposure.

Note: REGEN-COV is not a substitute for vaccination against COVID-19 and is not authorized for pre-exposure prophylaxis to prevent COVID-19. And the U.S. CDC defines close contact as someone who has been within six feet of an infected person (laboratory-confirmed or a clinically compatible illness) for a cumulative total of 15 minutes or more over a 24-hour period.

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