EMA initiates rolling review of Regeneron’s COVID-19 mAb
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
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The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
The clinical trial testing the REGN-COV2 antibody cocktail should be altered, according to the Independent Data Monitoring Committee (IDMC).
REGN-COV2 will be evaluated alongside standard-of-care in a Phase III study as part of the COVID-19 RECOVERY trial.
Simultaneous Phase III trials evaluating Regeneron’s REGN-COV2 antibody as both a prophylactic and a treatment have begun in US and some South American locations.