Passive Immunization Antibody Proceeds to Prevent COVID-19 in Immunocompromised Europeans

Despite the World Health Organization declaring an end to the recent pandemic about a year ago, COVID-19 remains a significant health risk for immunocompromised patients.

To address this unmet need, AstraZeneca today announced its Marketing Authorisation Application for sipavibart (AZD3152), an investigational long-acting monoclonal antibody, has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA) for preventing COVID-19 in immunocompromised patients. 

This passive immunization is essential for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

Prof. Paul Loubet, M.D., Ph.D., MPH, Professor of infectious diseases, University of Montpellier, head of the Infectious and Tropical Diseases Department, Nîmes University Hospital, France, and SUPERNOVA clinical trial investigator, said in a press release on July 1, 2024, “The disease burden of COVID-19 remains high for immunocompromised patients who are disproportionately impacted compared to the general population, despite vaccination."

"With cases expected to rise in the winter months, adding more pressure to stretched healthcare systems, sipavibart has the potential to be an important option for immunocompromised patients who remain at risk, and it has demonstrated COVID-19 protection in a mixed variant environment.”  

In addition to the EMA, AstraZeneca is in dialogue with other regulatory authorities on potential authorization or approval pathways for sipavibart.