The EU approved two drugs, Ronaprev (casirivimab/imdevimab) and Regkiron (regdanvimab) for the treatment of coronavirus. The European Medicines Agency's (EMA) Committee on Medicinal Products for Human Use (CHMP) has recommended their approval, according to the regulator's press office.
"Treatment with Ronaprev or Regquiron significantly reduces hospitalizations and deaths in patients with Covid-19 at risk for severe Covid-19. Another study showed that Ronaprev reduces the likelihood of contracting Covid-19 if a family member is infected with SARS-CoV-2, the virus that causes Covid-19," the committee concluded.
In particular, Ronaprev can be used to treat Covid-19 in adults and adolescents (12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk for serious illness. Ronaprev can also be used to prevent coronavirus in people 12 years of age and older with a body weight of at least 40 kilograms. The application for certification of Ronaprev was submitted by Roche Registration GmbH.As for Regquiron, the committee recommended that the drug be approved for the treatment of adults with Covid-19 who do not need supplemental oxygen and who are also at increased risk for serious disease. The developer of this drug is Celltrion Healthcare Hungary Kft.
CHMP will now send its recommendations for both drugs in the European Commission for quick making of the legally compulsory decisions.
Ronapreve and Regkirona are the first monoclonal antibody drugs to receive a positive CHMP approval for coronavirus. They are also on the list of covid drugs for the first time since Veklury (remdesivir) was recommended for authorization in June 2020.
Monoclonal antibodies are proteins designed to attach to a specific target, in this case the SARS-CoV-2 spike protein, which the virus uses to enter human cells.