EU regulator backs COVID-19 drugs from Regeneron-Roche, Celltrion – Community News

EU regulator backs COVID-19 drugs from Regeneron-Roche, Celltrion

The exterior of EMA, European Medicines Agency can be seen in Amsterdam, Netherlands December 18, 2020. REUTERS/Piroschka van de Wouw

  • EMA supports Ronapreve of Regeneron-Roche
  • Also supports Regkirona from Celltrion
  • European Commission decides on approval

Nov. 11 (Reuters) – The European drug regulator has recommended two COVID-19 antibody therapies — one from US-Swiss partners Regeneron-Roche and another from Celltrion in South Korea, as the region builds its defenses against rising cases.

European Commission approval would be the first for any COVID-19 treatment on the continent since Gilead’s (GILD.O) remdesivir last year.

Reuters reported earlier this week that the approval of the two drugs by the European Medicines Agency (EMA) was imminent. read more

Regeneron-Roche (REGN.O), (ROG.S), Ronapreve’s antibody cocktail was supported by the EMA’s Human Medicines Commission for the treatment of adults and children over 12 years of age with COVID-19 who do not require oxygen support and are at high risk for serious illness.

Celltrion’s (091990.KQ) Regkirona was only recommended for adults with similar conditions.

Ronapreve can also be used to prevent COVID-19 in people over the age of 12 who weigh at least 40 kilograms, the EMA said.

The two treatments are based on a class of drugs called monoclonal antibodies, which mimic natural antibodies produced by the human body to fight infection.

While the potential approval process is underway, the two medicines are already available to some patients in the European Union, as the EMA assisted Member States with early use in some cases.

Regeneron’s antibody cocktail was granted emergency marketing authorization in the United States last year and conditional marketing authorization in Britain in August.

The EU has secured about 55,000 courses of the therapy, a European Commission spokesman said in June.

The block does not have a supply agreement with Celltrion, whose antibody treatment has so far only been approved in South Korea.

Thursday’s recommendation comes after Eli Lilly (LLY.N) withdrew its application for EU approval of its antibody-based treatment last week, citing a lack of demand from EU member states as the bloc targets other suppliers. . read more

Reporting by Pushkala Aripaka in Bengaluru Additional reporting by Yadarisa Shabong Editing by Arun Koyyur and Mark Potter

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