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HHS stands ready with 600,000 courses of new antibody treatment against Omicron

The Eli Lilly drug awaits emergency use authorization from the FDA.

Susan Morse, Executive Editor

Photo: Alexandru Pavalache Eye Em/Getty Images

The federal government has purchased 600,000 treatment courses of a new monoclonal antibody treatment that data shows works against the Omicron variant. 

Omicron currently is estimated to make up about 100% of all COVID-19 cases in the United States. 

The new monoclonal antibody treatment, bebtelovimab, manufactured by Eli Lilly and Co., needs emergency use authorization (EUA) from the U.S. Food and Drug Administration before being distributed.

If approved for an EUA, the Department of Health and Human Services will immediately make the treatment available for free.

HHS would receive approximately 300,000 treatment courses of this monoclonal antibody in February and approximately 300,000 treatment courses in March. 

WHY THIS MATTERS

Early data suggests that this new product by Lilly has activity against both Omicron and the BA.2 Omicron subvariant. 

Should the BA.2 subvariant grow in proportion in the U.S., this potential treatment would help ensure there is a monoclonal antibody treatment that works against that strain of the virus.

The contract also includes a future option for 500,000 more doses and was awarded as a result of collaboration between the HHS Office of the Assistant Secretary for Preparedness and Response and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

However, HHS's top priority is getting vaccines and booster shots into arms to prevent people from getting sick in the first place, said HHS Secretary Xavier Becerra.

THE LARGER TREND

Monoclonal antibody treatments include those made by Lilly, Regeneron and GlaxoSmithKline and Vir Biotechnology. In January, GlaxoSmithKline and Vir  announced that the federal government was purchasing an additional 600,000 doses of sotrovimab, its investigational monoclonal antibody for the early treatment of COVID-19.

Already this year, HHS has provided more than 2.5 million COVID-19 treatments and therapies to states for Americans who have COVID-19. This includes antiviral pills, monoclonal antibodies and pre-exposure prophylaxis therapies for people with compromised immune systems.

In December 2020, UnitedHealth Group partnered with Eli Lilly to test the efficacy of its COVID-19 monoclonal antibody treatment, bamlanivimab, for patients at high risk of adverse outcomes.

In September 2021, the FDA revised the EUA for bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prevention for COVID-19 in adults and pediatric patients 12 years of age and older at high risk for progression to severe COVID-19, including hospitalization or death.

ON THE RECORD

"Under President Biden's leadership, we are prepared for the challenges we face with COVID-19 and are laser-focused on saving lives," Becerra said. "We have more COVID-19 treatments than ever before, we are providing a billion free at-home tests, and we have enough vaccines to get everyone vaccinated and boosted. If authorized by FDA, this purchase will add an additional 600,000 courses of treatment to our nation's 'medicine cabinet' that could help prevent severe outcomes for Americans who do get sick with COVID-19."
 
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com