AstraZeneca’s Sipavibart Approved in Europe and Japan for COVID-19 Prevention
AstraZeneca is pleased to announce that sipavibart (AZD3152) has received approval in Europe and Japan for the indication of prevention of symptomatic disease caused by SARS-CoV-2 infection!
These approvals are based upon the results of the SUPERNOVA Phase III COVID-19 prevention trial. This study showed that administration of sipavibart statistically significantly reduced the risk of development of symcompared with control (tixagevimab/cilgavimab or placebo) in the immunocompromised population1. The immunocompromised population includes patients with hematologic malignancies, organ transplant recipients, endstage renal disease patients requiring dialysis, patients within 1 year after B-cell depleting therapy, and patients taking immunosuppressive agents.
This study achieved its two primary endpoints. One was a reduction in the relative risk of developing symptomatic COVID-19 that was caused by all variants of SARS-CoV-2 and the other was a reduction in the relative risk of developing symptomatic COVID-19 that was caused by SARS-CoV-2 variants without the F456L mutation.
Data from the SUPERNOVA trial has been accepted for publication in an upcoming peer-reviewed medical journal.
Results will be presented to the investigators and site staff following the publication.
We wish to give a huge thanks again to all the participants, investigators, and study staff for their involvement in the sipavibart clinical studies (SUPERNOVA and Little DIPPER) which have helped to achieve this successful licensure.
Written by Lee-Jah Chang on behalf of the entire AstraZeneca sipavibart team
References