FDA pulls last COVID-19 monoclonal antibody treatment as new variants rise

Monoclonal antibody drugs to treat COVID-19 infections are no longer available in Minnesota, health officials have confirmed. 

The U.S. Food and Drug Administration on Wednesday announced it had ended emergency use authorization for Eli Lilly’s monoclonal antibody treatment for COVID-19, Bebtelovimab, in light of the rising BQ.1 and BQ.1.1 variants.

The decision comes amid data that the drug is not expected to be effective at treating the latest COVID-19 variants circulating across the country, according to the FDA. 

The latest COVID-19 wastewater data from the Metropolitan Council indicates the BQ.1 strain is now dominate in the Twin Cities and beginning to surge, with the variant accounting for about 58% of the COVID-19 viral particles entering the wastewater plant. 

Bebtelovimab had previously been given emergency use authorization for the treatment of mild-to-moderate COVID-19 in certain pediatric and adult patients at higher risk of severe illness or death from the virus. 

Two monoclonal antibody treatments — Bamlanivimab and Etesevimab — lost authorization in January amid the Omicron surge. Another monoclonal antibody drug — Sotrovimab — lost authorization in March.

“As of now, there are no monoclonal antibodies for treatment of acute infection that are authorized for use anywhere in the U.S.,” Garry Bowman, spokesperson for the Minnesota Department of Health, confirmed Friday. “So this is not just an issue here in Minnesota.” 

This week’s announcement from the FDA regarding Bebtelovimab, which was the last monoclonal antibody treatment still authorized for COVID-19 in the U.S., has increased fears among many physicians and high-risk patients about the winter ahead. 

According to Bowman, at least 11,362 courses of Bebtelovimab were given to patients in Minnesota since its authorization earlier this year. 

However, the actual number is likely much higher as Bowman said not all providers report their usage and the state only tracks products in the government’s supply — not drugs purchased commercially. 

Paxlovid, Veklury, Lagevrio and convalescent plasma treatments remain authorized for the treatment of COVID-19 in eligible patients in the U.S., according to the FDA.

Bowman said Minnesotans at higher risk of developing severe illness should contact their healthcare provider if they test positive for COVID-19 to learn what might be right for them. 

“Oral antivirals are effective against all of the current circulating variants and are still authorized and recommended for use,” he said. 

Evusheld, another defense for immunocompromised Americans, is also still available in Minnesota. 

The monoclonal antibody therapy doesn’t treat COVID-19, but it’s rather used as a pre-exposure prophylaxis to help certain high-risk patients avoid catching the virus in the first place. 

However, many experts believe Evusheld is also on shaky ground and quickly headed towards the same fate as Bebtelovimab. 

While Evusheld remains available in U.S. for now, the FDA last month warned some emerging variants were not neutralized by the therapy.