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Evusheld
Published
Product name
Evusheld
Active ingredient
Tixagevimab/cilgavimab
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Evusheld (tixagevimab/cilgavimab) was approved for the following therapeutic use:
Evusheld (tixagevimab and cilgavimab) has provisional approval for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg,
- who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination or
- for whom vaccination with any approved COVID-19 vaccine is not recommended due to a history of severe adverse reaction (for example., severe allergic reaction) to a COVID 19 vaccine(s) and/or COVID‐19 vaccine component(s).
See Section 4.2 Dose and method of administration and Section 5.2 Pharmacokinetic properties.
Evusheld is not recommended as a substitute for vaccination in individuals for whom COVID 19 vaccination is recommended.
This decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety data from ongoing clinical trials.
How this medicine works
Tixagevimab and cilgavimab are two recombinant human immunoglobulin G1κ (IgG1κ monoclonal antibodies, with amino acid substitutions to extend antibody half life (by M252Y/S254T/T256E (YTE) modification) and to reduce antibody effector function and potential risk of antibody-dependent enhancement of disease (by L234F/L235E/P331S (TM) modification). Tixagevimab and cilgavimab can simultaneously bind to non overlapping regions of the spike protein receptor binding domain (RBD) of severe acute respiratory syndrome coronavirus 2 (SARS CoV 2). Tixagevimab, cilgavimab and their combination bind to the spike protein with equilibrium dissociation constants of KD = 2.8 pM (picomolar), 13.0 pM and 13.7 pM, respectively, blocking its interaction with the human angiotensin converting enzyme 2 (ACE2) receptor, resulting in a blockade of virus entry and effectively neutralising SARS CoV 2. Tixagevimab, cilgavimab and their combination blocks RBD binding to the human ACE2 receptor with half maximal inhibitory concentration (IC50) values of 0.32 nM (nanomolar) (48 ng/mL), 0.53 nM (80 ng/mL) and 0.43 nM (65 ng/mL), respectively.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Evusheld was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
N/A