Product Dossier
KAVIGALE
Product Dossier for KAVIGALE (sipavibart, AstraZeneca). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: AstraZeneca
- Active ingredient: sipavibart
- Therapeutic area: Infectious Disease
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Kavigale is sipavibart 300 mg in 2 mL (150 mg/mL), supplied as a solution for injection/infusion in a vial.
Approved indications
— Pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who are immunocompromised due to a medical condition or receipt of immunosuppressive medications or treatments.
Key safety warnings
Kavigale is not recommended as a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
Regulatory history
Kavigale was approved by the TGA on 2025-05-20 for pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who are immunocompromised, based on positive evaluation of its quality, non-clinical, and clinical data. The TGA's quality and non-clinical evaluators had no objections to the approval. Clinical evaluation, primarily based on the pivotal Phase III SUPERNOVA study, supported the safety and efficacy of Kavigale for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals. The drug demonstrated a median half-life of 81 days, though some in vitro neutralisation limitations against specific XBB subvariants were noted. Kavigale was first listed on the ARTG on 2025-05-22.