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Regkirona
Published
Product name
Regkirona
Active ingredient
Regdanvimab
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Regkirona (regdanvimab) was approved for the following therapeutic use:
Regkirona has provisional approval for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 (see Section 5.1 Pharmacodynamic properties, clinical trials).
The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from assessment.
How this medicine works
Regdanvimab is a recombinant human immunoglobin G, subclass 1(IgG1) monoclonal antibody that binds to the receptor binding domain (RBD) of the spike(s) protein of severe acute respiratory syndrome coronavirus (SARS-CoV-2) consequently blocking SARS-CoV-2 cell entry and infection.
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 Regkirona was considered favourable for the therapeutic use approved.
ARTG details
N/A