COVID antibodies from Roche, Celltrion backed for approval in EU

The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to be backed for full approval in the EU.

Ronapreve (casirivimab and imdevimab) – developed and distributed by Regeneron as REGN-COV in the US – has been recommended by the CHMP for the treatment and prevention of COVID-19 in people aged 12 years and older weighing at least 40kg.

Regkirona (regdanvimab) meanwhile should be cleared for treating adults with COVID-19 who do not require supplemental oxygen and are at increased risk of developing severe disease, according to the panel.

The two antibodies could become the first drugs to be approved in the EU for coronavirus since the European Commission gave a green light to Gilead’s antiviral therapy Veklury (remdesivir) in June last year.

A final decision is expected in the coming weeks, although some patients in the EU are already being treated with the antibodies under early-access programmes.

The EMA’s committee looked at data from studies showing that treatment with Ronapreve or Regkirona significantly reduces hospitalisation and deaths in COVID-19 patients at risk of severe disease.

Another study showed that Ronapreve reduces the chance of having COVID-19 if a household member is infected with SARS‐CoV‐2.

Ronapreve has also been granted emergency use authorisations in the US and UK, although a green light in the EU could be the first for Celltrion’s antibody outside its home market of South Korea.

Last week, Eli Lilly withdrew its application for EU approval of its antibody combination bamlanivimab/etesevimab, with the CHMP saying there were still some questions to be answered about the medicine’s quality.

Lilly said the decision was down to a lack of demand, with EU focusing instead on other antibody suppliers. The company has however just agreed a $1.3 billion supply deal with the US federal government. So far, the EU has placed orders for Ronapreve as well as another antibody developed by GlaxoSmithKline and Vir.

The CHMP’s recommendations come as EU countries are experiencing a sharp increase in the number of COVID-19 cases, raising alarm bells for healthcare systems across the bloc as winter approaches.

In Germany, for example, there were more than 50,000 cases new cases yesterday, with 235 deaths attributed to COVID-19.

The World Health Organization said yesterday that the moment the Europe/Central Asia region is the only one in the world where COVID-19 cases and death rates are on the increase, with a 10% increase in mortality over the last week.

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