FDA Rescinds Authorization For Regeneron, Eli Lilly COVID-19 Antibody Treatments: Here's Why

Antibody treatments made by Regeneron Pharmaceuticals Inc REGN and Eli Lilly And Co LLY are not likely to work against the Omicron variant of COVID-19 and their emergency use authorization has been rescinded by the U.S. Food And Drug Administration.

What Happened: The regulator said in a statement, “data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.”

The treatments may be authorized in certain geographic regions if patients in those places are likely to be infected or exposed to a variant that is susceptible to them, said the FDA.

Why It Matters: FDA cited data from the Centers for Disease Control and Prevention and said the Omicron variant accounts for more than 99% of cases in the United States.

The regulator said it was highly “unlikely” that COVID-19 patients in the U.S. at this time are infected with a variant other than Omicron.

“This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant,” the agency said.

FDA said other treatments like Pfizer Inc’s PFE Paxlovid, Gilead Sciences,  Inc'sGILD Veklury (remdesivir), and Merck & Co., Inc's MRK molnupiravir “are expected to work against the omicron variant.”

It was reported earlier that the demand for monoclonal antibody treatments has outstripped supply and regulators are considering limiting authorization for certain treatments that have yet to show efficacy against Omicron.

Price Action: On Monday, Regeneron shares closed mostly unchanged at $621.48 in the regular session. On the same day, Eli Lilly shares traded 1.1% lower at $240.42 in the regular session.

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Posted In: AntibodiesCovid-19OmicronPandemicBiotechNewsFDAGeneral