Story at a glance
- Florida was forced to cancel more than 2,000 appointments for people to receive monoclonal antibody treatments on Tuesday.
- That’s because the Food and Drug Administration announced it was revoking emergency use authorization for two monoclonal antibody drugs used to treat COVID-19.
- The drugs are made by Eli Lilly and Regeneron, and clinical data has shown they aren’t effective in fighting off the omicron variant.
The Food and Drug Administration (FDA) revoked emergency use authorization for two monoclonal antibody drugs used to treat COVID-19, and that caused the Florida Department of Health to overnight cancel more than 2,000 appointments for people to receive the treatment.
Florida Gov. Ron DeSantis (R) released a statement detailing how the FDA acted without advance warning to states or health care providers. DeSantis said thousands of Floridians have received monoclonal antibody treatments and the FDA’s decision has “forced trained medical professionals to choose between treating their patients or breaking the law.”
On Monday the FDA published a press release announcing the decision to revise emergency use authorization for two monoclonal antibody treatments, Eli Lilly’s bamlanivimab and etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab), to limit their use to only when a patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.
“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States,” said the FDA.
The FDA said currently the omicron variant accounts for more than 99 percent of all U.S. COVID-19 cases, which means neither Eli Lilly’s nor Regeneron’s monoclonal antibody treatments are approved for use against it.
The FDA’s revocation of emergency use authorization comes a month after Eli Lilly announced it had found its monoclonal antibody treatment had a “reduced neutralization activity” against the omicron variant. Regeneron made a similar statement in December, saying its monoclonal antibody treatments have “diminished potency” against omicron.
However, earlier this month DeSantis announced he had secured 15,000 doses of Regeneron for Floridians, while calling on the Biden administration to allow for even more supply.
That supply is now in question, as the FDA’s ruling will limit the use of Regeneron for now. There is a chance it could be approved for use again in the future, with the FDA saying if patients in certain geographic regions are likely to be infected or exposed to a variant that has been proven to be susceptible to Eli Lilly’s or Regeneron’s monoclonal antibody treatments, then use of the treatments may be authorized in those regions.
However, DeSantis’s administration was not supportive of the move to restrict use of the treatments.
“Monoclonal antibody treatments like Regeneron have had a positive impact for thousands of Floridians. For the CDC and FDA, which have been consistently inconsistent throughout the entire pandemic, to restrict treatment does nothing but put individuals at risk,” said Jeanette Nuñez, lieutenant governor, in a statement.
There are other COVID-19 therapies available for states like Florida, like Paxlovid, sotrovimab, remdesivir and molnupiravir, and all are expected to work against the omicron variant and have FDA approval.
However, some of those treatments, like Paxlovid and molnupiravir are in short supply, with data from Health Human Services (HHS) revealing only about 264,000 patient courses of Paxlovid have been distributed across the U.S. Both drugs only recently began distribution in the U.S. last month.
Supply issues were also seen in Texas, when the HHS Texas office anounced it had exhausted its supply of sotrovimab and would have to cancel existing appointments until additional doses were sent in by the federal government.
Outside of all the available treatment options for COVID-19, the FDA noted that none are a replacement for a COVID-19 vaccine for those who are eligible to get one.
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