Bebtelovimab Not Currently Authorized for Emergency Use in U.S.
On November 30th, U.S. Food and Drug Administration announced bebtelovimab not currently authorized for emergency use in U.S.; it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1., according to data included in the Health Care Provider Fact Sheet.
Nowcast Data from the CDC published last week estimates the combined proportion of COVID 19 cases caused by the Omicron.
Given the likelihood that infection is likely to be caused by a non-susceptible variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time.
Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice by the Agency. Additionally, the Administration for Strategic Preparedness and Response (ASPR) has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative.
The U.S. Government recommends all product be retained in the event thatSARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.
Please also See the 11/30/22 DSHS letter to therapeutics providers for complete details.
- There are several treatments authorized or approved which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1.
- Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg).
- Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) who are: hospitalized, or not hospitalized.
- Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
Reminder: Shelf-Life Extensions
ALL COVID-19 therapeutics have received extensions for some or all lots. Please check with the manufacturer before removing any products from the proper storage conditions.
NOTE: ASPR continues to work with product manufacturers to maximize shelf-life. We will provide any updates for upcoming expiration dates as soon as we receive.
Please find an addition listing of expiration extensions from the FDA here.
Maintain all monoclonal antibodies under proper refrigerated temperatures, even if they are not currently authorized for use. It is expected that will be authorized again in the future for use against new strains of SARS-COV2.
Evusheld Fact Sheet Update
The Evusheld Fact Sheet has been updated to reflect In-vitro neutralizing data for several Omicron subvariants.
Section updated:
- Microbiology (12.4): updated neutralizing data including data in table below.
Implications:
- Evusheld is unlikely to be active against BF.7, BA.2.75.2, BQ.1 and BQ.1.1.
- Evusheld does retain neutralization activity against BJ.1.
-
Refer to section 5.3 in the EVUSHELD Fact Sheet for further information on Risk for COVID-19 Due to SARS-CoV-2 Viral Variants Not Neutralized by EVUSHELD.
-
FDA continues to recommend EVUSHELD as an appropriate option for pre-exposure prophylaxis to prevent COVID-19.
- Breakthrough infections are possible. Advise patients to have a treatment plan in place and to seek timely medical attention if symptoms occur.
Refer to FDA releases important information about risk of COVID-19 due to certain variants not neutralized by EVUSHELD and table below (Table 6 in Fact Sheet).
Now Enabled: On Site Destruction of Expired or Unauthorized Product
HPOP has enabled reporting for all licensed provider locations with destruction procedures in place that follow all federal, state, and local regulations. Therapeutics can be destroyed on site only if:
- Guidelines are followed on what product can be destroyed.
- Only allowed for expired product or unauthorized product that can no longer be stored.
- No unexpired product that is currently authorized for use can be destroyed.
- Sites are following established protocols for destruction and attest in HPOP to following all regulations.
- Quantities of any product destroyed is recorded in HPOP.
The established manufacturer returns process for each product is still an option for sites who do not have an established method for proper destruction or otherwise prefer to go through the returns process
- Returned product must also be recorded in HPOP.
|
