The US FDA has revised the emergency use authorizations for Regeneron and Eli Lilly’s COVID-19 antibody treatments after the drugs proved ineffective against the omicron variant.
Eli Lilly’s monoclonal antibody (mAb) treatments – bamlanivimab and etesevimab (administered together) and Regeneron’s REGEN-COV (casirivimab and imdevimab) will be limited to use only “if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments,” the US Food and Drug Administration (FDA) said in a statement.
The organization said the data showcases that the treatments are extremely unlikely to be successful at protecting individuals against the omicron variant, and thus the drugs are not authorized for use in any US states, territories, and jurisdictions at this time.
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Adjusted capacity
Regeneron said in January 2021 it had adjusted much of its internal manufacturing activities to increase its ability to produce the antibody cocktail. Less than a year later, the firm claimed it could adapt REGEN-COV to be effective against the Omicron variant, if necessary. Now, the firm told BioProcess Insider it is “Evaluating next steps as it relates to manufacturing capacity and so forth, in light of our efforts to support the development for our next generation antibody candidate and will provide updates as appropriate.”
Additionally, it is “Working urgently and collaboratively with the FDA to determine how to bring additional safe and effective mAb treatments to patients as quickly as possible. Pending regulatory discussions, new therapeutic candidates could enter the clinic in coming months.”
Meanwhile, Lilly said its capacities have been designed “for variations in demand and [that they] will balance that capacity across other activities.” Additionally, the company are encouraging “Sites to hold onto their stock of bamlanivimab and etesevimab for potential future use.”
Lilly also pointed to its statement from December, saying its third investigational antibody therapy against COVID-19, bebtelovimab “demonstrate[s] our antibody potently inactivates all known variants of concern, including Omicron.”
“We have initiated a US submission for bebtelovimab. We are urgently working with the FDA to potentially bring bebtelovimab to market under emergency use authorization; we cannot speculate on timing for potential regulatory action.”
The FDA has said the pause would continue until further data emerges on their efficacy against Omicron.