The European Union’s drug agency has recommended the approval of two monoclonal antibody treatments for Covid-19 — Celltrion’s Rekirona and Regeneron-Roche’s Ronapreve.
The Committee for Medicinal Products for Human Use (CHMP), which works under the European Medicines Agency (EMA) has recommended the application of South Korean pharma giant Celltrion’s Rekirona in adult patients aged 18 and older, the EMA said in a statement on Friday.
While the committee backed Regeneron-Roche’s Ronapreve (also known as casirivimab/imdevimab) for treating Covid-19 in adults and adolescents from 12 years of age who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, Yonhap News Agency reported.
Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2, which the virus uses to enter human cells.
In reaching its conclusion, the CHMP evaluated data from studies showing that treatment with Ronapreve or Regkirona significantly reduces hospitalisation and deaths in Covid-19 patients at risk of severe Covid-19. Another study showed that Ronapreve reduces the chance of having Covid-19 if a household member is infected with SARSaCoVa2, the virus that causes Covid-19.
The European Commission, which is authorised to approve medicines in the region, is expected to issue its decision within two months on the CHMP opinion.
The approval would mark the first for any Covid-19 treatment in Europe since Gilead’s remdesivir last year.
Celltrion is currently conducting a phase three clinical study of Rekirona in 13 countries on 1,315 critically ill Covid-19 patients.
In February, Rekirona won the South Korean drug safety agency’s conditional approval, becoming the first locally made treatment for Covid-19.
The drug won its first overseas approval for an emergency application from Indonesia and Brazil, the report said.