The Food and Drug Administration has revoked its emergency use authorizations for two monoclonal antibodies that have served as COVID-19 treatment mainstays in long-term care facilities.
Eli Lilly’s bamlanivimab and etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab) “are not authorized for use in any U.S. states, territories and jurisdictions at this time,” FDA stated. The two therapies have been shown to be ineffective against the relatively new omicron variant, which now accounts for 99% of COVID-19 cases nationwide, the agency said.
The move to revoke authorization altogether was made based on “the most recent information and data available,” and could be reversed if the drugs are found to work against future variants, the FDA added.
Clinicians are now left with one effective monoclonal antibody drug — GlaxoSmithKline’s sotrovimab — for use in non-hospitalized COVID-19 patients at risk of severe illness. The other recommended early-treatment choices for this population include two antiviral pills, Paxlovid and molnupiravir, and the infused antiviral drug Veklury (remdesivir). The FDA on Monday expanded the use of remdesivir, the only fully FDA-approved COVID-19 treatment, to include non-hospitalized patients, opening up another care option for patients earlier in the disease course.
Paxlovid, molnupiravir, sotrovimab, and Veklury (remdesivir) “are expected to work against the omicron variant” and are recommended for patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, the FDA said. The problem is that the first three treatments are in short supply.
A National Institutes of Health panel on Monday released recommendations for choosing between these treatments in order of preference when supplies are scarce.