CHMP positive for Kavigale, (sipavibart) for the prevention of COVID‑19 in immunocompromised people aged 12 years and older.- AstraZeneca.
On 12 December 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Kavigale, intended for the prevention of COVID‑19 in immunocompromised people aged 12 years and older.
Kavigale was reviewed under EMA’s accelerated assessment programme. The applicant for this medicinal product is AstraZeneca AB.
Kavigale will be available as 300 mg solution for injection and infusion. The active substance of Kavigale is sipavibart, an immunoglobulin, antiviral monoclonal antibody (ATC code: J06BD09). Sipavibart is a recombinant human IgG1 monoclonal antibody that provides passive immunisation against SARS-CoV 2 by binding its spike protein receptor binding domain.
The benefit of Kavigale is a reduction in the risk of developing symptomatic COVID-19 due to any SARS-CoV-2 variant compared to comparator (either tixagevimab plus cilgavimab or placebo), in immunocompromised people aged 12 years and older. The reduction was greater for disease attributed to matched (non-F456L mutation containing) SARS-CoV-2 variants.
The most common side effects with Kavigale are injection site reaction when given as intramuscular injection, and infusion site and related reactions when given by intravenous infusion.
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