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FDA Authorizes Revisions to Evusheld Dosing

June 29, 2022

Therapeutic Updates

The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPR’s updates related to COVID-19 monoclonal antibody therapeutics, please see our full list of updates.

There are different variants (and subvariants) of SARS-CoV-2, and FDA continues to evaluate how well Evusheld (tixagevimab co-packaged with cilgavimab) neutralizes them. Currently, the Omicron BA.2, BA.2.12.1, BA.4, and BA.5 subvariants are circulating in the United States. Nonclinical data and pharmacokinetic modeling suggest that activity against these subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab.

Therefore, on June 29, 2022, FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval.

The FDA continues to monitor the neutralizing activity of Evusheld against emerging SARS-CoV-2 variants and will provide additional updates as needed.

For further details, please refer to the FDA’s Frequently Asked Questions for Evusheld.