We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Ronapreve
Published
Product name
Ronapreve
Active ingredient
Casirivimab/imdevimab
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Ronapreve (casirivimab/imdevimab) was approved for the following therapeutic use:
Ronapreve has provisional approval for the indications below:
Treatment:
Ronapreve is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.
Post-exposure prophylaxis:
Ronapreve is indicated for the prevention of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to SARS-CoV-2 and who either:
- have a medical condition making them unlikely to respond to or be protected by vaccination, or
- are not vaccinated against COVID-19. (refer to Section 4.2 Dose and method of administration and 5.1, Clinical Trials)
Ronapreve is not intended to be used as a substitute for vaccination against COVID-19.
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 ongoing clinical trials and post-market assessment.
How this medicine works
Casirivimab immunoglobulin G, subclass 1, kappa light chain (IgG1κ) and imdevimab immunoglobulin G, subclass 1, lambda light chain (IgG1λ) are two recombinant human monoclonal antibodies which are unmodified in the fragment crystallisable (Fc) regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor binding domain (RBD) of severe acute respiratory syndrome coronavirus (SARS-CoV-2) with dissociation constants KD = 45.8 picomolar (pM) and 46.7 pM, respectively. Casirivimab, imdevimab and casirivimab and imdevimab together blocked RBD binding to the human angiotensin converting enzyme 2 (ACE2) receptor with half maximal inhibitory concentration (IC50) values of 56.4 pM, 165 pM and 81.8 pM, 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 Ronapreve was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
N/A