Local expert says data back FDA decision to halt monoclonal treatments

COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don't work against the omicron variant of COVID, the FDA says.

JACKSONVILLE, Fla. – Florida Gov. Ron DeSantis launched an attack against the Biden administration in the wake of the FDA move revoking authorization for the use of COVID-19 antibody drugs from Regeneron and Eli Lilly. That decision from the federal agency led to the shutdown of all monoclonal antibody treatment centers in Jacksonville and statewide.

The move to revoke authorization was not unexpected because the drugmakers said the infusion drugs are less able to target omicron because of its mutations. Omicron now accounts for nearly all U.S. infections.

“So this to me is not new news,” said Dr. Mo Reza, an infectious disease specialist in Jacksonville. “The data from the laboratory studies have shown that effectiveness just goes down pretty dramatically. And this is coming from the companies themselves which are for-profit companies.”

This has become a political issue. DeSantis condemned what he calls “the Biden administration’s reckless and sudden decision.” DeSantis said, “Without a shred of clinical data to support this action Biden has forced trained medical professionals to choose between treating their patients or breaking the law… it will cost some Americans their lives.”

Reza said there is data showing the drugs are not effective in fighting omicron.

“So I’m a clinician and I can talk to you about the clinical aspect of science that we’re seeing, and what we’re seeing now is 99% of new infections are due to omicron across our country,” said Reza. “And these two monoclonal antibodies are not effective in doing what they need to do to minimize the risk of severe disease. And this is in the laboratory studies. We don’t have clinical data yet but that can take months to come out.

“A good example is when omicron was first diagnosed in South Africa. Initially, it took us weeks to get that clinical and that laboratory data about how effective our vaccines were,” Reza continued. “That’s kind of same thing we do with this medication as well. A lot quicker data comes available through the laboratory studies. And then we have to look for clinical data as time goes on. But that may take months. In the meantime, we in medicine want to do no harm.”

The FDA said restricting the use of the monoclonal drugs would eliminate unnecessary drug side effects, including allergic reactions.

For those battling COVID there are alternative therapies available and the FDA just ramped up the use of Remdesivir to treat more patients.

“They’re available in limited supply. So sotrovimab, which is a monoclonal antibody that does work to decrease your risk of hospitalization and death by 85%. Remdesivir, which is another medication, anti-viral, that they can use in the outpatient setting to decrease your risk of hospitalizations. And there are other oral medications: Paxlovid and another medication by Merck that are also shown to reduce your risk of hospitalization,” Reza said. “But granted, these are in limited supply at this point, but these are other fantastic options that are coming available and are available at this point.”

Reza and others in the medical community are quick to point out none of this is a substitute for vaccinations and that vaccinations and mask-wearing remain the best defenses in the fight against COVID.

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