FDA Revokes Emergency Use Authorizations for Four COVID-19 Monoclonal Antibody Products
Key Insights
The FDA has revoked the Emergency Use Authorizations (EUAs) for four monoclonal antibody products used in the U.S. government's COVID-19 (search) response.
The revoked EUAs include treatments from Eli Lilly, AstraZeneca, Vir Biotechnology, and Regeneron Pharmaceuticals due to the rise of resistant SARS-CoV-2 variants.
These monoclonal antibody products have not been authorized for patient administration for over a year because of ineffective against current variants.
The U.S. Food and Drug Administration (FDA) has revoked the Emergency Use Authorizations (EUAs) for four monoclonal antibody (MAb) products previously authorized for emergency use in response to the COVID-19 (search) public health crisis. This decision, made at the request of the individual product sponsors, impacts several treatments that were once key tools in managing the pandemic.
The revoked EUAs include Eli Lilly’s bebtelovimab, AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), Vir Biotechnology’s sotrovimab, and Regeneron Pharmaceuticals’ REGEN-COV (casirivimab and imdevimab). These products have not been authorized for administration to patients for over a year due to the prevalence of SARS-CoV-2 variants against which they are ineffective.
The FDA had previously limited the use of each product based on the emergence of resistant variants, allowing healthcare facilities to retain inventory in anticipation of potential changes in variant susceptibility. However, the persistence of non-susceptible variants and the expiration of shelf life for most product lots led to the current revocation.
Impact and Alternatives
The revocation means these specific monoclonal antibody treatments are no longer authorized for use in the United States. Healthcare providers will receive instructions from each product's sponsor regarding the return and disposal of existing supplies.
While these EUAs have been revoked, other options remain available for managing COVID-19 (search). Antiviral medications like nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio) are still approved or authorized for high-risk outpatients. Additionally, pemivibart (Pemgarda) remains authorized for pre-exposure prophylaxis in immunocompromised individuals who may not mount an adequate immune response to vaccination. Pemivibart is authorized for individuals 12 years and older, weighing at least 40 kg, with moderate-to-severe immune compromise due to medical conditions or immunosuppressant medications. It is not intended for post-exposure prophylaxis or treatment of active SARS-CoV-2 infection.
Current Variant Landscape
According to the CDC's Nowcast tracker, the XEC variant is currently the most common circulating strain of SARS-CoV-2, accounting for approximately 44% of cases, followed by KP.3.1.1 at 39%. The FDA had recently expressed concerns about the susceptibility of newer variants to pemivibart but later reversed its position.
The FDA emphasizes that healthcare providers should stay informed about the latest data on variant susceptibility to make informed treatment decisions for patients with COVID-19 (search).