DHS Health Alert Network

Bebtelovimab is no longer authorized for COVID-19 Treatment

Bureau of Communicable Diseases

December 1, 2022

Key Points

• The FDA has announced that bebtelovimab, a monoclonal antibody for the treatment of COVID-19, is no longer authorized in the United States.
• Bebtelovimab is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1. These subvariants are increasing in prevalence across the Midwest.
• Commercial distribution of bebtelovimab has been paused indefinitely. The COVID-19 treatments Paxlovid, Veklury, and Lagevrio are expected to retain activity against BQ.1 and BQ.1.1.
• Patients who test positive for COVID-19 and are at risk for severe disease may be referred to the new DHS Telehealth Service to be evaluated for treatment. Patients may access the service via the online portal or by calling 1-833-273-6330.

On November 30, the US Food and Drug Administration announced that bebtelovimab is no longer authorized for emergency use in any US region. FDA based this decision on the rapidly increasing prevalence of the Omicron subvariants BQ.1 and BQ.1.1 which are highly resistant to bebtelovimab. According to the CDC NowCast, BQ.1 and BQ.1.1 accounted for 49.4% of variants circulating in the Midwest during the week ending in 11/26/22, and this proportion is expected to continue to increase. FDA, CDC, and NIH are closely monitoring SARS-CoV-2 variants that may impact the use of other therapies authorized for emergency use. Evusheld, the monoclonal therapy used for pre-exposure prophylaxis of COVID-19, has also shown reduced neutralization activity against BQ.1 and BQ.1.1 but remains authorized at this time.

Authorized distributors have paused commercial distribution of bebtelovimab until further notice. FDA recommends that all bebtelovimab be retained in the event susceptible variants become more prevalent in the future.

Providers are encouraged to use other authorized or approved products that retain activity against BQ.1 and BQ.1.1. Please refer to the NIH clinical guidelines for the latest treatment recommendations. Paxlovid (ritonavir-boosted nirmatrelvir) remains the preferred treatment for patients at risk for severe disease, followed by Veklury (remdesivir). Lagevrio (molnupiravir) may be considered when other therapeutics are not available, feasible to use, or clinically appropriate.

Patients who test positive for COVID-19 and are at risk for severe disease may access a COVID-19 Treatment Telehealth Appointment to be evaluated for treatment. This new service from DHS is available 7 days per week from 8 a.m. to 8 p.m. Patients may access the service via an online portal or by calling 1-833-273-6330.

Resources

• FDA Bebtelovimab press release
• NIH Clinical Guidelines for Therapeutic Management of Nonhospitalized Adults with COVID-19
• DHS COVID-19 Telehealth Service

Thank you for your attention to this issue,

Jonathan Meiman, MD
Chief Medical Officer and State Epidemiologist
Environmental and Occupational Health
Division of Public Health
Wisconsin Department of Health Services

Ryan Westergaard, MD, PhD, MPH
Chief Medical Officer and State Epidemiologist
Bureau of Communicable Diseases
Division of Public Health
Wisconsin Department of Health Services

About the Wisconsin Health Alert Network

The content of this message is intended for public health and health care personnel and response partners who have a need to know the information to perform their duties. The HAN will be the primary method for sharing urgent and time-sensitive public health information with clinical and public health partners. Health care providers and other officials can subscribe and unsubscribe using their preferred email address at the DHS COVID-19 website.