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Evusheld
Published
Product name
Evusheld
Active ingredient
Tixagevimab and cilgavimab
Submission type
New biological entity and change in dosage and change to Product Information requiring evaluation of new data
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Evusheld (tixagevimab and cilgavimab) was approved for the following therapeutic use:
Treatment
Evusheld has provisional approval for the treatment of adults with COVID-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. See Section 4.2 Dose and method of administration and Section 5.2 Pharmacokinetic properties.
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 trial.
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 (YTE) and to reduce antibody effector function and potential risk of antibody-dependent enhancement of disease (TM). 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 spike protein with equilibrium dissociation constants of KD = 2.8 pM, 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 the SARS-CoV-2 virus. Tixagevimab, cilgavimab and their combination blocked RBD binding to the human ACE2 receptor with half maximal inhibitory concentration (IC50) values of 0.32 nM (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
- 378245