FDA halts use of monoclonal therapy widely pitched by DeSantis; Gov vows to fight back

Regeneron monoclonal antibody therapy is not an effective treatment for COVID-19 omicron infections and can no longer be used, with just a few exceptions, the U.S. Food and Drug Administration announced Monday evening. The FDA also halted distribution of the Lilly brand of monoclonal antibody therapy for the same reason.

But Gov. Ron DeSantis said Tuesday morning he would fight the action, which shuttered Regeneron clinics he opened just this month amid doubts about the therapy’s efficacy against omicron infections.

“This not based on a clinic trial. This is not even peer-reviewed,” DeSantis said.

Actually, even Regeneron concurs with the FDA’s action, saying the therapy it developed to great effect against delta-variant infections does not help against omicron infections.

“The original REGEN-COV antibody cocktail has been administered to millions of people, and we are extremely proud of the critical role this medicine has played during the pandemic. However, it does not work against #Omicron in lab tests, which tells us that unfortunately it is also not going to work in people infected with this variant,” says a statement provided Tuesday by a Regeneron spokesman. “According to the CDC, over 99% of COVID-19 cases in the U.S. are now caused by the Omicron variant, and thus we believe the FDA’s decision to amend the Emergency Use Authorization was appropriate at this time.”

The statement goes on to say the company will “now focus on creating safe treatment options that will work against Omicron, as well as Delta and other variants of concern. We have a next generation candidate that, based on preclinical studies, appears to do just this. We are in the process of scaling up and completing the necessary requirements to begin human testing. We’ll continue to work closely with the FDA to determine how to bring new safe and effective antibody treatment options to patients as quickly as possible.”

DeSantis railed against the FDA decision at a press conference Tuesday morning. He claimed the FDA based its decision on a “single, non-peer-reviewed, non-clinical study that was actually done by a consultant for a rival company to the other two monoclonal antibody treatments,” he said. The Phoenix forwarded to the governor’s office the Regeneron statement concurring with the FDA’s decision and asked for the source of his statements.

At the press conference, DeSantis said: “We have had people use it and we’ve had good results. It’s not 100 percent, we understand that, but you also don’t even know when someone goes in whether it’s omicron or still the delta — yes, mostly in Florida it’s going to be omicron at this point — but it’s really a reckless decision to take this option away from patients.”

“It was very effective against delta. … But even if with omicron, if it’s half as effective or even 25 percent as effective, that’s better than nothing for people,” he argued.

DeSantis’ comments Tuesday followed his condemnation of the FDA’s move in a press statement released late Monday. The Florida Department of Health confirmed the clinics are shut down.

“Based on Centers for Disease Control and Prevention data, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15. Therefore, 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,” wrote Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement published Monday.

She continued: “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 manufacturers of the two monoclonal antibody therapies previously announced that their products, which were highly successful at treating delta-variant infections, are not effective against the highly mutated and now dominant omicron strain of COVID.

Regeneron issued this statement about its compound of casirivimab and imdevimabon on Dec. 16, citing “diminished potency versus Omicron.”

Lilly issued this statement about its compound of bamlanivimab and etesevimabon on Dec. 20, including this summary: “As expected, we have confirmed reduced neutralization activity of bamlanivimab with etesevimab against the Omicron variant of concern.”

“Because data show these treatments [Regeneron and Lilly brands] are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” Cavazzoni said in Monday’s FDA announcement.

In their joint statement Monday night, DeSantis and Surgeon General nominee Joseph Ladapo accused the “Biden administration” – actually the FDA — of depriving the public of “lifesaving treatments.” DeSantis described the FDA’s decision to deauthorize use of the two monoclonal antibody therapies as “haphazard” and “reckless,” an “indefensible edict” constituting “medical authoritarianism” that subjects doctors to the “whims of a failing president.”

Ladapo did not address the details of the dispute, but 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.’”

Neither DeSantis nor Ladapo addressed the FDA’s rationale for deauthorizing the therapies nor the manufacturers’ own statements about the diminished effectiveness of their products in the omicron-dominant environment.

The FDA, operating under various titles since 1906, is the nation’s leading authority on “protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation,” according to its mission statement and historical data.

The FDA most recommends Pfizer and Moderna vaccinations to fight COVID sickness. It also points to emerging COVID treatments, including antiviral pills produced by Pfizer and Merck and a monoclonal antibody therapy called sotrovimab, as being safe and effective for use against omicron infections, along with remdesivir, which has been widely used to treat various strains of COVID throughout the pandemic.

Cavazzoni said the Regeneron and Lilly products will be reserved for use in areas where patients are highly likely to be infected with a variant other than omicron, should there be any.