On March 15, the National Agency for the Safety of Medicines and Health Products (Ansm) issued a temporary authorization for the use of two synthetic antibody dual therapies: the dual therapy casirivimab and imdevimab, developed by the Roche laboratory and the bamlanivimab and etesevimab dual therapy, developed by the Lily France laboratory. These treatments are intended for patients at risk of being affected by severe forms of Covid-19. "These monoclonal antibodies are designed to specifically target the S protein located on the surface of SARS-CoV-2, thereby neutralizing the ability of the virus to bind to and enter human cells. ", Ansm explained in a document.
Synthetic antibodies to protect people at risk
Monoclonal antibody treatments are intended for patients who may develop acute forms of the disease "due to immunosuppression related to a pathology or treatments, advanced age or the presence of comorbidities ". According to Ansm, clinical studies have shown these treatments to be effective when given early in the disease. Patients who may benefit from synthetic antibody bithherapy are:
- people with an immunity deficit associated with a pathology or with treatments such as chemotherapy, solid organ transplantation, kidney disease, lupus, immunosuppressive treatment.
- patients with disease at risk for complications such as idiopathic pulmonary fibrosis, amyotrophic lateral sclerosis, trisomy 21 and myopathy.
- people aged 70 to 80 with co-morbidities such as obesity, complicated high blood pressure, chronic kidney disease and diabetes.
The Ansm, however, recalled that no monoclonal antibody has received marketing authorization (MA) in the European Union for the treatment of coronavirus infection. "A continuous assessment procedure for an MA application for these two combinations of monoclonal antibodies is underway at the European Medicines Agency (EMA) ", also said the National Medicines Agency.
Are monoclonal antibodies effective against variants?
The administrations of synthetic antibodies will be carried out by infusion in a health establishment five days after the appearance of the first symptoms. For health authorities, dual therapy could reduce the risk of complications such as hospitalizations in intensive care.
To benefit from monoclonal antibody treatments, however, patients must not be positive for the South African and Brazilian variants. In question ? Health authorities do not know if these treatments are effective against these new strains of coronavirus. A PCR test is therefore mandatory if the circulation of the two variants exceeds 10% in the territory where the patient lives.
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