FDA bans ‘Trump’ antibody treatment — Analysis
Florida’s health officials were furious at the sudden changes in monoclonal antibody rules.
US Food and Drug Administration (FDA), has cancelled its emergency authorizations for two types of monoclonal anti-body treatments made by Eli Lilly and Regeneron. According to the regulator, both therapeutics are not suitable for use. “highly unlikely to be active against the omicron variant.”
The FDA revoked the authorization and neither of the drugs are now on the market in the US. FDA permitted that they may be reauthorized in the future. “in certain geographic regions”Patients who have been exposed to SARS CoV-2 strains and are still at risk.
Monoclonal antibodies are lab-produced cells that mimic the work of a human immune system, helping a patient’s body deal with the infection. The antibody “cocktail”Regeneron’s treatment for Covid-19 was widely used by Donald Trump in his October 2020 case. This treatment can be quite expensive. It’s usually used to avoid severe symptoms in patients at high risk.
Florida health officials responded with outrage to the news. This conservative state is unique among all other states in that it refuses to mandate vaccinations for its citizens.
The state made monoclonal anti-bodies drugs available as part of its Covid-19 response last year.
Florida Department of Health condemned the “abrupt decision of the federal government”They claimed it meant that Florida would have to temporarily shut down monoclonal antigen sites. Florida stated that it did not agree with FDA’s decision, as the FDA failed to present clinical evidence supporting its scientific validity.
In vitro Omicron resistance was seen in monoclonal anti-body treatments. This has been reported in scientific journals. GlaxoSmithKline’s anti-micron antibody Sotrovimab (a competitor product that is currently in clinical trials in China) was reported to be able to protect some of its potential against this new strain.
Regeneron admitted publicly that Omicron’s drug was ineffective.
The FDA said other treatments against Covid-19 remained available, including Sotrovimab, and various antivirals, like Gilead’s injectable drug remdesivir and the pills developed by Pfizer and Merck.
Sotrovimab was one of the monoclonal medications used in Florida. However, the drug is rarely used. The Tampa Bay Times published an earlier January report that 140 doses were administered in Florida by hospitals in one week, as opposed to the 2,737 Regeneron doses over the same time period.
The federal government’s earlier decision to pause shipments of the drugs produced by Regeneron and Eli Lilly was criticized by Florida Governor Ron DeSantis. He claimed that Omicron was not the only strain in circulation.