EMA approves two new human monoclonal antibodies for COVID treatment

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The committee for Medicinal Products for Human Use (CHMP) of the European Medical Agency (EMA), recommended authorisation of two more human monoclonal antibodies for COVID treatment, a statement released by the agency said.

The CHMP recommended authorisation to Roche’s Ronapreve,  (casirivimab/imdevimab)  and Celltrion Healthcare’s Regkirona (regdanvimab) for treating patients with mild to moderate COVID infections not requiring oxygen support.

While Ronapreve received clearance for treating patients of 12 years or more, Regkirona was cleared for treating adult patients with mild to moderate COVID infections not requiring oxygen supplementation.

The CHMP will now send its recommendations for both medicines to the European Commission for rapid legally binding decisions, the statement added.

Monoclonal antibodies are proteins designed to attach to the spike protein of SARS-CoV-2, which the virus uses to enter human cells.

Evaluating the data of the clinical trials CHMP found that both Ronapreve and Regkirona use reduced the risk of hospitalisation among the mild to moderate COVID patients as well as reduced the risk of infections among the contacts, the statement added.

Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for COVID-19 and join the list of COVID-19 products that have received a positive opinion since Veklury (remdesivir) was recommended for authorisation in June 2020.

The medicines’ benefits are greater than their risks for their approved uses, CHMP concluded.


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