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

(Precision Vaccinations)

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

The FDA's EUAnow 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 EUAto treatnon-hospitalized patients.

"Today's FDA authorization enables certain people at high risk ofdeveloping severe COVID-19 infectionto access REGEN-COV if they have beenexposedto the virus the first time an antibody treatment has been authorized for this purpose," statedGeorge D. Yancopoulos, M.D., Ph.D., President and CEOof 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 theU.S.population may not respond fully to COVID-19 vaccination because of immunocompromising conditions or immunosuppressive medicines.

This group includespeople 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 EUAenables 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. CDCdefines close contact as someone who has been withinsix feet of an infected person(laboratory-confirmed or aclinically compatible illness) for a cumulative total of 15 minutes or more over a 24-hour period.

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