Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
On Monday the FDA issued a statement that they were pulling their authorization of two monoclonal antibody treatments which had previously been used for treatment of COVID patients.
Dr. Patrizia Cavazzoni, the Director of the Center for Drug Evaluation and Research said in a press release that due to the fact that “these treatments are highly unlikely to be active against the Omicron variant” the medications will no longer be authorized under emergency use in “any U.S. states, territories, and jurisdictions at this time.” However, as the science changes, this decision may change if new data proves that monoclonal antibody treatments are effective against new or emerging strains according to the statement.
The decision to no longer use the COVID-19 antibody drugs, Regeneron and Eli Lilly (bamlanivimab and etesevimab), came after an independent panel of experts issued the recommendations based on the lack of efficacy of the drugs when used to treat COVID-19 patients infected with the Omicron variant. Omicron is currently the dominant strain, accounting for 99% of infections in the United States.
The drugs are less effective due to the multiple mutations; however, drug manufacturers are working on monoclonal antibody treatments that will specifically target the Omicron variant.
The statement comes amidst short supply of FDA approved medications that can be used to treat patients prior to hospitalization. Additionally, the FDA has only authorized a list of four drugs (paxlovid, sotrovimab, remdesivir and molnupiravir) that can be used to treat patients, further exacerbating the supply shortage.
The FDA recently expanded remdesivir’s use to include adults and children with an early diagnosis of COVID-19 who have an increased risk for hospitalization. The drug had previously only been authorized for administration in a hospital setting. Experts suggest that early treatment may likely reduce the need for hospitalizations, something critics have been saying since the start of the pandemic.
While remdesivir is one of the few treatment options, it is not without risk.
A study shows that the drug prevents an important enzyme in the breakdown of medications from working appropriately which impacts the intestine, liver, and kidneys. Research indicates that this inhibition is irreversible, and the authors of the study believe physicians should exercise extreme caution when administering the drug. Recently, the drugmaker also had to recall 55,000 vials that were contaminated with glass shards.
While the drug may prevent severe respiratory disease, one study indicates that this treatment may result in longer hospital stays and there is little data to support improvement in survival rates of patients who receive the drug.
This new decision by the FDA has drawn criticism, namely from Governor Ron DeSantis who has been outspoken in support of monoclonal antibody treatment.
DeSantis made his disapproval of this decision clear, saying, “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,” he also added “there are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”
White House Press Secretary Jen Psaki argued that the medications don’t work against the Omicron variant, but that the administration is providing Florida with drugs that do work such as vaccines, boosters, and antiviral therapy. This, however, seems to contradict data that suggests the vaccines and subsequent booster shots are also proving ineffective against the Omicron variant as they are failing to prevent hospitalizations or transmission of the virus.