Two drugs based on a combination of two synthetic antibodies are authorized to treat early, from the onset of symptoms, the adults most at risk of severe forms of COVID-19, the National Security Agency announced on Monday. drug and health products (ANSM).
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This first authorization in France of bitherapies based on synthetic antibodies concerns REGN-COV2, a combination of casirivimab and imdevimab from the Roche laboratory (co-developed by Regeneron) and the treatment combining bamlanivimab and etesevimab, from the Lilly France laboratory, specifies the ANSM.
The health agency has put in place “two temporary authorizations” to allow the use of these dual therapies in people at high risk of developing a severe form of COVID-19 “due to immunosuppression linked to a pathology or treatments [chimiothérapie, NDLR] of advanced age or the presence of comorbidities ”.
Those over 80, those on dialysis, kidney transplant recipients, and those 70 to 80 who are obese or diabetic are on the list.
Patients should not require oxygen therapy due to COVID-19.
According to the ANSM, “preliminary data from clinical studies suggest an interest of these treatments in the management of people at high risk of progressing to a severe form of COVID-19, when they are administered at the very beginning of disease.”
This is to try to prevent them from worsening their condition leading to hospitalization and resuscitation.
The administration of these treatments should be carried out no later than five days after the onset of symptoms. It is performed as a single intravenous infusion, under supervision, in a health facility.
As a precaution, in the event of circulation of the South African or Brazilian variant exceeding 10% in a territory, a PCR screening test is imperative. If the patient is variant positive, these treatments should not be used due to doubts about their effectiveness in this case.
To date, no synthetic antibody, called a monoclonal antibody, has a marketing authorization (AMM) in the European Union for the treatment of the COVID-19 disease, recalls the health agency.
A rolling review procedure for an MA application for these two dual therapies is underway at the European Medicines Agency.
The French Minister of Health, Olivier Véran, announced at the end of February that France had ordered “tens of thousands of doses of monoclonal antibodies from a higher generation”, expected “in mid-March”.
This remark by the minister came when the country had just authorized a first synthetic antibody isolated, in monotherapy, from the American laboratory Eli Lilly. A decision that had raised criticism among the medical community doubting its usefulness.