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. | 
No comments:
Post a Comment