Available online 22 February 2023
Author links open overlay panel, , , , , SummaryIntroduction: Casirivimab and imdevimab (Ronapreve®) are two recombinant human monoclonal antibodies (mAbs) that bind to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, preventing the virus from entering cells. In March 2021, this drug was granted emergency use authorisation (EUA) in France for early treatment of COVID-19 in patients at increased risk of progression to severe COVID-19. In August/September 2021, the indication was expanded to COVID-19 prevention (pre- or post-exposure prophylaxis) and treatment of hospitalised patients requiring non-invasive oxygen therapy. The aim of the study was to better describe the adverse drug reaction (ADR) profile and detect safety signals of this new drug used in COVID-19 treatment.
Methods: We described Adverse Drug Reaction (ADR) profile with casirivimab/imdevimab reported as suspect/interacting drug to the French pharmacovigilance network and the pharmaceutical company between 17/03/2021 and 30/06/2022. Data presented correspond to the 2 periods of the pharmacovigilance survey: the first carried out by the pharmaceutical company for curative and prophylactic uses and the second by Toulouse University regional pharmacovigilance center (RPVC).
Results: A total of 384 cases were analysed and 256 were "serious". ADR profile was comparable between the 2 periods and between curative and prophylactic use, corresponding to expected ADRs such as infusion-related reactions and hypersensitivity, inefficiencies or worsened infections and deaths. Two potential pharmacovigilance signals were also studied: acute pulmonary oedemas and sudden deaths.
Discussion: No pharmacovigilance signal emerged from this 15 months French pharmacovigilance survey. Moreover data from published studies are also reassuring. This pharmacovigilance survey was the first one for the new version of EUA and with a new ADR reporting process i.e declaration to the RPVC instead of the pharmaceutical company. Casirivimab/imdevimab is no longer used in France today but we continue to monitor this drug for any future evidence of resurgent activity on a new variant of Sars-CoV-2.
AbbreviationsANSMAgence nationale de sécurité du médicament et des produits de santé
COVID-19coronavirus disease 2019
EUAemergency use authorization
FDAFood and Drug Administration
FPVDFrench pharmacovigilance database
MAmarketing authorization
mAbsmonoclonal-antibodies
MedDRAMedical Dictionary for Regulatory Activities
PrePpre-exposure prophylaxis
RPVCRegional PharmacoVigilance Center
SARS-CoV-2severe acute respiratory syndrome coronavirus 2
WHOWorld Health Organization
KEYWORDSCasirivimab imdevimab
Ronapreve
Monoclonal antibodies
Pharmacovigilance
Pharmacovigilance survey
Adverse drug reaction
COVID-19
SARS-CoV-2
View Abstract© 2023 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.
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