Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID‑19 in an immunocompromised patient population.AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. Sipavibart is an investigational long-acting antibody designed to provide COVID-19 protection for immunocompromised patients who often do not