March 18, 2022

The High Health Authority (HAS) authorizes early access to Evusheld® (a combination of two monoclonal antibodies, tixagevimab and cilgavimab), as a preventive treatment for Covid-19, for patients 12 years of age and older who weigh more than 40 kg, immunocompromised and weakly or does not respond to vaccination.

On December 9, 2021, the High Health Authority (HAS) authorized early access to Evusheld® (a combination of two monoclonal antibodies, tixagevimab and cilgavimab) as a preventive treatment for Covid-19. This authorization benefited patients over 18 years of age, who responded weakly or not to vaccination, and who belong to one of the subgroups at very high risk of severe form of Covid-19 as defined by the ANRS-Infectious Diseases Emerging[1] or to those who are not eligible for vaccination and are at high risk of contracting a severe form of Covid-19.

Since then, the National Agency for the Safety of Medicines and Health Products (ANSM) has issued opinions modifying the summary of product characteristics, its instructions and its protocol for therapeutic use and data collection (PUT-RD). In his opinion of March 7, he considers in particular that safety and efficacy are strongly presumed for all immunocompromised patients who also respond weakly or do not respond at all to vaccination.

In addition, adolescents aged 12 years and over and weighing more than 40 kg are now eligible for early access under the same conditions as the adult population.

The HAS, based on the opinions of the ANSM, authorizes early access to this treatment for all these people, including in particular patients with solid cancer or patients on dialysis, under the same conditions as in its first decision.

HAS reminds that this treatment is not intended to be used as a substitute for vaccination and that the implementation of treatments with monoclonal antibodies does not exempt patients and their families from complying with barrier measures. They are strongly advised to wear a mask in places of significant promiscuity, in places where respect for barrier gestures is limited, as well as in poorly ventilated closed places.

[1] Solid organ transplant recipients, allogeneic hematopoietic stem cell transplant recipients, lymphoid blood diseases: treated or untreated chronic lymphoid leukemia, non-Hodgkin’s lymphoma, and myeloma in treatment, including patients receiving CAR-type gene therapy Therapeutic biphenotypic antibodies or of T cells, patients treated with anti-CD20 antibodies or BTK inhibitors or azathioprine, cyclophosphamide and mycophenolate mofetil, subjects with primary immunodeficiency.

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