Primary source: View
Kavigale has received marketing authorization effective January 20, 2025, allowing its use for the prevention of COVID-19 in at-risk populations, specifically immunocompromised individuals.
The authorization allows Kavigale to be used in a clinical setting, providing a new option for preventing COVID-19 in a vulnerable patient population, emphasizing the need for continued monitoring of safety and effectiveness.
Healthcare professionals must administer Kavigale in a monitored clinical environment to manage potential severe allergic reactions, including anaphylaxis.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Healthcare professionals must administer Kavigale in a monitored clinical environment to manage potential severe allergic reactions, including anaphylaxis.
The European Medicines Agency (EMA) has authorized Kavigale (sipavibart) for use in the European Union. It is indicated for the prevention of COVID-19 in individuals aged 12 and older who have compromised immune systems. This medicine is administered as a single injection in the muscle or via intravenous infusion in a clinical setting.
What changed: Kavigale has received marketing authorization effective January 20, 2025, allowing its use for the prevention of COVID-19 in at-risk populations, specifically immunocompromised individuals.
Why it matters: The authorization allows Kavigale to be used in a clinical setting, providing a new option for preventing COVID-19 in a vulnerable patient population, emphasizing the need for continued monitoring of safety and effectiveness.
Practical implication: Healthcare professionals must administer Kavigale in a monitored clinical environment to manage potential severe allergic reactions, including anaphylaxis.
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