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Xevudy
Published
Product name
Xevudy
Active ingredient
Sotrovimab
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Xevudy (sotrovimab) was approved for the following therapeutic use:
Xevudy has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death (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 ongoing clinical trials and post-market assessment.
How this medicine works
Sotrovimab is an engineered human immunoglobulin G (IgG)1 monoclonal antibody (mAb) that binds to a highly conserved epitope on the spike protein receptor binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high affinity (dissociation constant Kd = 31 ng/mL). The fragment crystallizable region (Fc) domain of sotrovimab includes M428L and N434S amino acid substitutions (LS modification) that extends antibody elimination half-life, but does not impact wild-type Fc-mediated effector functions when compared with the original mAb with LS modification (S309+LS) in cell culture.
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 Xevudy was considered favourable for the therapeutic use approved.
ARTG details
N/A