FDA Extends Antibody Review by Three Months

Monoclonal antibodies have yet to receive full FDA approval.

Regeneron Pharmaceuticals Inc. announced last week that the U.S. Food and Drug Administration (FDA) has extended its review of the company’s monoclonal antibody treatment by three months.

The FDA had approved Regeneron’s “cocktail” of two monoclonal antibodies, casirivimab and imdevimab, for emergency use during the height of the pandemic, but rescinded the emergency authorization after the treatment was ineffective against the Omicron strain of COVID-19. The treatment, known as REGEN-COV, has not yet been fully approved for use in the United States.

The FDA has not requested that additional scientific studies be conducted, but they did request additional data from Regeneron’s previous studies to consider during this three-month period.

As the Lord Leads, Pray with Us…

  • For FDA Commissioner Califf as evaluations of therapies and medications are considered for possible approval.
  • For Director Walensky to seek God’s guidance as she heads the CDC.
  • For Secretary Becerra to have wisdom as he oversees the various agencies under the Department of Health and Human Services.

Sources: The Hill, Reuters


Back to top