Covid, Ema approves first 2 monoclonal therapies

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA has recommended authorizing two therapies based on monoclonal antibodies against Covid-19. These are Ronapreve * (casirivimab / imdevimab) and Regkirona * (regdanvimab). The experts’ decision was announced by the EMA itself, which explains how these are the “first monoclonal antibodies” anti Sars-CoV-2 “recommended for marketing authorization” by the EU body. Read also The committee recommended authorizing Ronapreve for the treatment of Covid in adults and adolescents from 12 years of age, and weighing at least 40 kilograms, who do not require supplemental oxygen and who are at increased risk of worsening their illness. Ronapreve can also be used to prevent Covid in people aged 12 and over who weigh at least 40 kilograms. The company that applied for the authorization was Roche Registration GmbH. As for Regkirona, the CHMP recommended authorizing the medicine for the treatment of adults with Covid-19 who do not require supplemental oxygen and who are also at increased risk of worsening the disease. The applicant for Regkirona was Celltrion Healthcare Hungary Kft. The CHMP will now send its recommendations to the European Commission “for swift and legally binding decisions”. Ronapreve and Regkirona are the first monoclonal therapies to receive a positive opinion from the CHMP and are added to the list of products for Covid that have received a positive opinion. Monoclonal antibodies – Ema recalls – are proteins designed to attach to a specific target, in this case the Spike protein that the Sars-CoV-2 coronavirus uses to enter human cells. To reach its conclusions, the CHMP evaluated data from studies showing that treatment with Ronapreve or Regkirona significantly reduces hospitalizations and deaths in Covid patients at risk of serious illness. Another study showed that Ronapreve reduces the chance of contracting Covid if a family member is infected with Sars-CoV-2. While the evaluation of the authorization applications was ongoing, the Committee provided support to EU Member States for the early use of these medicines. Indeed, the therapies in question were already available to some patients in the European Union.