Posted by Michael Wonder on 01 Jul 2024
Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
1 July 2024 - Submission based on positive SUPERNOVA Phase 3 trial data which demonstrated a statistically significant reduction in the incidence of COVID‑19 in an immunocompromised patient population.
AstraZeneca’s marketing authorisation application for sipavibart has been accepted under an accelerated assessment procedure by the EMA, for the pre-exposure prophylaxis of COVID-19 in immunocompromised patients.
