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FDA updates Sotrovimab emergency use authorization

Apr 05 2022


Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant


The Centers for Disease Control and Prevention (CDC) Nowcast data from April 5, 2022, estimates that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is above 50% in all Health and Human Services (HHS) U.S. regions. Data included in the health care provider fact sheet show the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Due to these data, sotrovimab is not authorized in any U.S. state or territory at this time.


Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients.


FDA will continue to monitor BA.2 in all U.S. regions and will provide follow-up communication when appropriate.



Update [3/30/2022] FDA limits use of Sotrovimab to treat COVID-19 in additional U.S. regions due to the BA.2 Omicron sub-variant


The Centers for Disease Control and Prevention (CDC) Nowcast data from March 29, 2022 estimates that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is above 50% in three additional Health and Human Services (HHS) regions (5, 9, and 10). Due to these data, FDA has added these regions to the list of states and territories where sotrovimab is not authorized at this time.


Sotrovimab is not authorized at this time in the following states and territories:

  • Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont (Region 1) (as of 3/25/2022)

  • New Jersey, New York, Puerto Rico, and the Virgin Islands (Region 2) (as of 3/25/2022)

  • Illinois, Indiana, Michigan, Minnesota, Ohio, and Wisconsin (Region 5) (as of 3/30/2022)

  • Arizona, California, Hawaii, Nevada, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, and Republic of Palau (Region 9) (as of 3/30/2022)

  • Alaska, Idaho, Oregon, and Washington (Region 10) (as of 3/30/2022)

Sotrovimab remains authorized in U.S. regions where the CDC Nowcast point estimate for the proportion of the Omicron BA.2 variant remains below 50%. FDA will continue to monitor BA.2 in all U.S. regions and may revise the authorization further to ensure that patients with COVID-19 have effective treatments available. Health care providers in regions where sotrovimab remains authorized should strongly consider the use of other approved or authorized products, and monitor the frequency of BA.2 in their region as they choose appropriate treatment options for patients.




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SOURCE :

https://www.fda.gov/fda-updates-sotrovimab-emergency-use-authorization