The US Food and Drug Administration (FDA) has revoked its emergency use authorizations for two kinds of monoclonal antibodies treatments produced by Regeneron and Eli Lilly. The regulator said the two therapeutics were “highly unlikely to be active against the omicron variant.”
With the authorization revoked, neither drug is now available for patients in the US. The FDA allowed that it may in the future re-authorize their use “in certain geographic regions” for patients exposed to SARS-CoV-2 strains that are still susceptible to them.
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” developed by Regeneron was famously used in the treatment of then-President Donald Trump when he contracted Covid-19 in October 2020. The treatment is relatively expensive and is usually administered to prevent severe symptoms in high-risk patients.