FDA Halts Bamlanivimab Distribution in Three States

 

With the increase of multiple variants of COVID-19 across the United States, the U.S. Food and Drug Administration (FDA) will limit the use of monoclonal antibody treatments developed by Regeneron and Eli Lilly due to concerns the medications are not effective against these new strains.

On Wednesday, Janet Woodcock, acting commissioner of the FDA, announced in a webinar with physicians from the American Medical Association that the government, which has control over distribution of the monoclonal antibodies, will not distribute Eli Lilly’s bamlanivimab to California, Arizona and Nevada, where those variants are more common. The FDA’s decision was first reported by Endpoints.

The rise of the new COVID strains has been concerning to health care professionals and drugmakers who wonder if the therapeutics and vaccines authorized against the initial strain of SARS-CoV-2 will be as effective in a real-world setting with new viral strains. Woodcock, according to the report, said the regulatory agency is positioned to screen the efficacy of the monoclonal antibodies against the emerging strains of COVID-19.

Earlier this week, the U.S. Centers for Disease Control and Prevention said the new COVID-19 strains that have emerged in California are “variants of concern.” According to CDC data, these variants may be 20% more transmissible and also noted that some of the therapeutics that have received EUA may not be as effective.

Woodcock’s announcement follows on the heels of letters issued by the FDA to Regeneron and Eli Lilly urging the companies to keep an eye on the rise of new strains, particularly the B.1.351 variant that first arose in South Africa. In those letters, which are for bamlanivimab alone and in combination with etesevimab and Regeneron’s monoclonal antibody, the FDA asked the two companies to “establish a monitoring genomic database(s) for the emergence of global viral variants of SARS-CoV-2” and provide monthly reports to the regulatory agency. Additionally, the FDA said it may require Eli Lilly and Regeneron to “assess the activity” of their monoclonal antibodies against any of the prevalent variants that harbor substitutions in the target protein.

Eli Lilly’s bamlanivimab, a neutralizing antibody initially developed by AbCellera, was approved by the FDA for emergency use authorization in November to treat mild-to-moderate COVID-19 patients. Eli Lilly’s bamlanivimab targets different sites on the SARS-CoV-2 spike protein. The combination of bamlanivimab and etesevimab gained Emergency Use Authorization in February for mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Eli Lilly is also assessing bamlanivimab in combination with a monoclonal antibody developed by Vir Biotechnology and GlaxoSmithKline. VIR-7831 is being studies in combination with bamlanivimab in low-risk patients with mild to moderate COVID-19.

According to the Endpoints report, an Eli Lilly spokesperson noted that preclinical data demonstrate the combination of bamlanivimab and etesevimab “maintains its neutralizing effect” against the emerging California variant.

Regeneron’s antibody cocktail, which was used to treat former President Donald Trump, was granted EUA in November. The monoclonal antibody cocktail is a combination of casirivimab and imdevimab. The treatment was authorized for use in mild to moderate COVID-19 patients age 12 and above, who have tested positive for the virus and are at high risk for progressing to severe COVID-19 and/or hospitalization.