New Monoclonal Antibody That Works Against Omicron

If It Receives EUA, This New Treatment by Lilly Would Be Provided to States Free of Charge and Add Another COVID-19 Treatment to Nation’s Medicine Cabinet

Purchase Demonstrates Biden-Harris Administration’s Preparedness for Future Needs Treating COVID-19, Reducing Severe Disease, and Protecting Americans

As part of the Biden-Harris Administration’s commitment to ensuring Americans who get sick with COVID-19 have access to treatments that work, today U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra is announcing that the federal government has purchased 600,000 treatment courses of a new monoclonal antibody treatment that data shows works against the Omicron variant. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge.

“Under President Biden’s leadership, we are prepared for the challenges we face with COVID-19 and are laser-focused on saving lives,” said Secretary Becerra. “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. Our top priority is preventing people from getting sick in the first place, which is why it is critical that Americans continue to get vaccinated and get their booster shot as soon as they’re eligible.”

HHS would receive approximately 300,000 treatment courses of this monoclonal antibody in February and approximately 300,000 treatment courses in March. Recently, it was determined that data shows that two monoclonal antibody treatments – one made by Lilly (bamlanivimab/etesevimab), and one made by Regeneron (REGEN-COV) – are highly unlikely to work against Omicron, which currently is estimated to make up about 100 percent of all COVID-19 cases in the U.S. 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 may help ensure that we can continue to offer monoclonal antibody treatment that works against that strain of the virus.

“We want to make sure if an American gets sick with COVID-19, they can get a treatment that works,” added Secretary Becerra.

If it receives EUA, HHS is prepared to immediately make this treatment available. Already this year, HHS has provided more than 2.5 million COVID-19 treatments and therapies to states for Americans who get sick with COVID-19 to use, including antiviral pills, monoclonal antibodies, and pre-exposure prophylaxis therapies for people with compromised immune systems.

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 (ASPR) and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

 
Note: All HHS press releases, fact sheets and other news materials are available at https://www.hhs.gov/news.