The U.S. Food and Drug Administration (FDA) has withdrawn its authorization for monoclonal antibody treatments manufactured by Regeneron
"Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses, like SARS-CoV-2," said Dr. Patrizia Cavazzoni, Director of the FDA Center for Drug Evaluation and Research. "And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as Omicron. This is the case with these two treatments for which we're making changes today."
Both Regeneron and Eli Lilly have backed the FDA's findings, stating that the treatments simply did not work against the variant. Eli Lilly's treatment was first approved in October 2020, with Regeneron's treatment (notable for being used in treating former President Donald Trump) receiving authorization later. Luckily for healthcare providers, the FDA has found that other medicines, including Pfizer's
Regeneron announced late last year that it had begun work on a new cocktail to treat Omicron variant Coronavirus. "I think we need to figure out a way that we can get this [new antibody therapy] to patients on a large scale before that next variant shows up," CEO Leonard Schleifer told CNBC just ahead of the holiday Omicron surge.
Despite the variety of other treatments available, conservatives have reacted negatively to the FDA's authorization withdrawal. Florida Governor Ron DeSantis, in particular, claimed that the FDA had acted "without a shred of clinical data" to support its action. This, of course, is quite to the contrary, with data from the FDA showing inefficacy against the Omicron variant and both manufacturers agreeing with said decision.
