The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended on Thursday 11 November that two monoclonal antibody-based medicines, Ronapreve and Regkirona, be authorised to treat Sars-CoV-2.
The committee recommended authorising Ronapreve for the treatment of the disease in adults and adolescents, aged 12 years and over and weighing at least 40 kilogrammes, who do not require supplemental oxygen and who are at risk of developing severe illness, and for the prevention of disease in persons aged 12 years and over and weighing at least 40 kilogrammes.
The same committee recommends that Regkirona be approved for the treatment of adults with coronavirus who do not require supplemental oxygen and who are also at increased risk of developing severe symptoms.
Ronapreve and Regkirona are the first monoclonal antibodies to receive a positive opinion from the CHMP to fight the virus, the institution said. They join the list of products that have received a positive opinion since remdesivir was recommended for approval in June 2020 (see EUROPE 12514/8).
The committee based its work on several studies. For the first drug, 0.9% of treated patients (11 out of 1,192 patients) were hospitalised or died within 29 days of treatment, compared to 3.4% of placebo patients (40 out of 1,193 patients).
When used for prevention, 29% (29 out of 100 people) of those who tested positive developed symptoms within 14 days of testing positive, compared to 42.3% (44 out of 104 people) of those who received a placebo.
For Regkirona, among patients at increased risk of worsening their disease, 3.1% of treated patients (14 out of 446) were hospitalised, required additional oxygen therapy, or died within 28 days of treatment, compared with 11.1% of placebo patients (48 out of 434). (Original version in French by Pascal Hansens)