In addition to the Pfizer vaccine, teens will now be able to receive treatment to avoid ending up in critical care services. From this Friday, all patients at high risk of having severe forms of Covid-19 will be able, from the age of 12, to benefit from two early treatments based on synthetic antibodies, announces the Agence du drug (ANSM).
The ANSM is thus extending the use of these dual therapies, which combine two synthetic antibodies, to people at high risk of Covid “regardless of their age from 12 years old”. These treatments, intended to avoid a worsening of their condition, had been authorized since mid-March in France, but only for adults, and for certain categories of them, at very high risk of developing a serious form of the disease ( those over 80, those on dialysis, kidney transplant recipients and those aged 70 to 80 who are obese or diabetic, etc.).
This expansion of the indications is intended to “meet the medical need in certain situations not covered to date,” said the ANSM on Tuesday. The decision concerns the REGN-COV2 treatment, 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, she notes.
Already 1000 patients have benefited from it
As of May 31, a little more than 1,000 patients had benefited from treatment with this type of dual therapy. The new beneficiaries are people “at high risk of developing a severe form of Covid-19, in particular due to severe immunosuppression”, as well as “patients with chronic pathology, regardless of their age from 12 years, such as obesity, complicated high blood pressure, diabetes, or chronic renal or respiratory failure ”and those with“ uncontrolled or AIDS-stage HIV infection ”.
The first authorization in mid-March was only aimed at adults at high risk “due to immunosuppression linked to a pathology or treatments (chemotherapy, editor’s note), of advanced age or the presence of comorbidities”.
The over 80s included dialysis patients and kidney transplant recipients in particular. But for obese or diabetics, the authorization was only for people aged 70 to 80. Patients should not require oxygen therapy.
If a specific mutation is detected, for example present on the Beta (first spotted in South Africa) or Gamma (which emerged in Brazil) variants, Roche dual therapy should be used, according to the health agency. .
To date, no synthetic antibody, called a monoclonal antibody, has a marketing authorization (AMM) in the European Union for Covid. A continuous assessment procedure for an MA request for these two bitherapies is underway at the European Medicines Agency (EMA), recalls the ANSM.