MIAMI – As Florida closed the sites that were distributing COVID-19 antibody drugs that were not effective against omicron, federal officials rushed to distribute treatments to states that were more efficient, officials said.
Data showed Regeneron and Eli Lilly infusions were not effective against omicron, so the U.S. Food and Drug Administration revoked its authorization for both drugs.
“We can confirm that the REGEN-COV antibodies do not work against the Omicron variant,” a representative for Regeneron said in a statement.
“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat patients with mild to moderate COVID-19 with bamlanivimab and etesevimab together in the U.S. evaluation of both pseudovirus and authentic virus confirm that they are not effective at treating the currently predominant Omicron variant,” Eli Lilly said in a statement Wednesday.
According to The U.S. Department of Health and Human Services, just this week the agency is providing Florida with 34,000 doses of treatments that do work against omicron.
“There are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant,” Dr. Patrizia Cavazzoni, the FDA’s Center for Drug Evaluation and Research director, said in a statement on Monday.
Walgreens also confirmed this week that COVID-19 oral antiviral medications are available at some locations for “eligible patients with a valid prescription from a prescribing healthcare provider, including telehealth providers.”
The medications “must be started within 5 days of symptom onset,” a statement from the company read. “Walgreens has shared with primary care providers participating store locations.”
Gov. Ron DeSantis vowed to fight President Joe Biden’s administration to allow the distribution of Regeneron and Eli Lilly antibody drugs. During a news conference, White House press secretary Jen Psaki said DeSantis is advocating for treatments that don’t work.
Below is the full statement sent Wednesday by Eli Lilly:
“Lilly continually monitors the COVID-19 environment and is committed to ensuring our antibodies are available, as appropriate, to patients as variants continue to evolve and their patterns of transmission and prevalence shift.
“The FDA has updated the Fact Sheet for bamlanivimab and etesevimab to include a new Limitation for Authorized Use: due to the high frequency of the Omicron variant, these therapies are not currently authorized in any U.S. region.
“Lilly and the FDA agree that it is not medically appropriate, at this time, to treat patients with mild to moderate COVID-19 with bamlanivimab and etesevimab together in the U.S. Evaluation of both pseudovirus and authentic virus confirm that they are not effective at treating the currently predominant Omicron variant. Authorization status will change as needed, depending on prevalence and trends of variants of concern.
“Authentic virus analysis of Lilly’s third investigational antibody therapy, bebtelovimab, confirm our earlier pseudovirus findings, which demonstrate our investigational antibody potently inactivates all known variants of concern, including Omicron. We are working urgently with the FDA to potentially bring bebtelovimab to patients through emergency use authorization. FDA review of the bebtelovimab submission is ongoing.”
12 p.m. report