Regulators yanked authorization for two treatments, saying they don't work against omicron
By Tom Howell Jr. - The Washington Times - Tuesday, January 25, 2022
Florida said it was closing its monoclonal antibody treatment sites late Monday after the Food and Drug Administration restricted the use of two drugs that haven’t been effective against the omicron variant of the coronavirus.
“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice,” the Florida Department of Health said.
Florida Gov. Ron DeSantis, a Republican, condemned the FDA‘s move and said 2,000 appointments were canceled on Tuesday alone. He said the decision to suspend the use of the Regeneron and Eli Lilly monoclonal antibody treatments was made abruptly and without notice or clinical data.
Mr. DeSantis has leaned hard into the monoclonal antibodies as a treatment of choice to help people who catch COVID-19 and may develop severe disease.
The Biden administration has promoted the monoclonals but generally hails the vaccines as the first line of defense against the coronavirus.
The administration is trying to procure more of a third monoclonal treatment, sotrovimab, from GlaxoSmithKline because it has proven effective against the omicron variant that accounts for 99% of U.S. cases.
“It’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time,” regulators said, referring to the Eli Lilly and Regeneron drugs. “This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant.”
The FDA said there are other treatments — including GSK monoclonals, the new Pfizer antiviral pill, remdesivir and molnupiravir — that remain effective against omicron.
Florida officials said they should have access to the full suite of monoclonals.
“In our field of medicine, when someone comes to you seeking a treatment that could save their life, it is essential to have treatment options to ensure health care providers can make the best decisions for their patients,” Florida Surgeon General Dr. Joseph Ladapo said. “The federal government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.’”
The FDA said its decision to yank authorization for the pair of antibody treatments might be temporary.
“In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions,” the agency said.