AstraZeneca’s MAA for sipavibart accepted by EMA for COVID-19 prevention

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 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 respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19. The EMA’s Committee for Medicinal Products for Human Use, CHMP, granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation. Accelerated assessment aims to reduce the timeframe for the CHMP to review a MAA compared to the standard procedure.