FDA Monoclonal Antibody Decision Pulled Into Political Fray

The FDA’s revision of the emergency use authorizations (EUAs) of two monoclonal antibody treatments for COVID-19 has taken on a political dimension. Florida Gov. Ron DeSantis, who has been promoting monoclonal antibody treatment of COVID-19, said at a press conference today that “we're going to fight back against this because this is just wrong,” reported Politico. “This is not the way you know that you help people.”

The FDA announced yesterday that it was revising the emergency use authorization for Regeneron’s casirivimab and imdevimab combination, which the company markets as REGN-COV and Eli Lilly’s bamlanivimab and etesevimab combination. The agency’s press release said data showed that it was “highly unlikely” that the treatments would be effective against an infection against the omicron variant circulating. The agency stopped short of revoking the EUAs for the treatment. Instead, they were “revised,” so they are not authorized for use in any U.S. “at this time.”

The Washington Post reported yesterday that HHS had notified state officials had it stopped distribution of REGEN-COV and Lilly’s monoclonal antibodies.

DeSantis, a Republican who is seen as potential candidate for the presidency in 2024, has been criticizing the Biden administration for months for how it has handled the distribution and supply of monoclonal antibodies. His office issued a strongly worded press release yesterday that quoted DeSantis as saying that “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.”

The FDA’s decision to, in effect, put the EUAs for the two monoclonal antibody treatments on hold came after a panel of outside experts advising the NIH on treatment guidelines for COVID-19 issued new guidelines on Friday (Jan. 21) that said because the omicron variant has numerous mutations to the spike protein that characterizes coronaviruses, “it is predicted to have markedly reduced susceptibility” to the bamlanivimab and etesevimab — panel use the generic names, not REGEN-COV — and casirivimab plus imdevimab.

There are several treatments for COVID-19 caused by the omicron variant , although they have been in short supply. In late December, the FDA issued EUAs for two antiviral agents for patients infected the omicron variant, Pfizer’s Paxlovid (ritonavir-boosted nirmatrelvir) and Merck’s molnupiravir. Sotrovimab, the COVID-19 monoclonal antibody developedby GlaxoSmithKline and Vir Technology, has proved to be effective against the omicron variant.