FDA restrict use of two monoclonal antibody treatments
pharmafile | January 25, 2022 | News story | Manufacturing and Production |
The FDA has shared that it is limiting the use of two monoclonal antibody therapies for the treatment of COVID-19, due to data indications the therapies are “highly unlikely” to be effective against the dominant Omicron variant, currently the dominant strain in the US.
The FDA revised the authorisations for Regeneron and Eli Lilly. In a statement released, the FDA shared:
“In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.”
Monoclonal antibodies are laboratory-created proteins mimicking the natural antibodies which the body produces, to fight off harmful pathogens. The Omicron variant, which began circulating in the US in November 2021, is now estimated to account for over 99% of cases in the US, as of 15 January, according to data released by the CDC. The FDA shared that “data show these treatments are highly unlikely to be active” against the Omicron variant.
“The NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recently recommended against the use of bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) because of markedly reduced activity against the omicron variant and because real-time testing to identify rare, non-omicron variants is not routinely available,” the FDA shared.
The agency went on to emphasise that several other therapies including Paxlovid and monupiravir are expected to work against the variant, “and that are authorised or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.” On 21 January the FDA additionally expanded approval of the antiviral drug remdesivir to treat more COVID-19 patients. Remdesivir was the first government-approved drug for COVID-19, previously limited to treat hospitalised patients.
Both Eli Lilly and Regeneron previously announced that they were developing new antibodies targeting the Omicron variant.
Ana Ovey
