EU regulator builds Omicron defences with approvals of Vir, Sobi drugs

* EMA approves Kineret and Xevudy for COVID-19 treatment

* Kineret for adults with pneumonia, lung failure risk

* Xevudy for adults, adolescents at risk of severe disease

By Pushkala Aripaka and Amna Karimi

Dec 16 (Reuters) - The European Union's drug regulator on Thursday approved a COVID-19 treatment from British-U.S. duo GSK GSK.L and Vir Biotechnology VIR.O and another from Swedish drugmaker Sobi SOBIV.ST , as the bloc builds its defences against Omicron.

The approval by the European Medicines Agency (EMA) of GSK-Vir's antibody drug Xevudy and Sobi's arthritis drug Kineret come as governments struggle with soaring infections and worry about the swiftly-spreading Omicron variant of the coronavirus.

EMA's human medicines committee recommended using Kineret to treat COVID-19 in adults with pneumonia requiring oxygen support and those at risk of developing severe respiratory failure.

GSK-Vir's Xevudy, chemically called sotrovimab, was recommended for adults and adolescents who did not require oxygen support but faced a higher risk their disease could worsen.

While a small number of allergic reactions were seen with Xevudy, its benefits outweighed any risks, as did Kineret's, EMA said.

With the latest approvals, the EU has approved six medicines for use against COVID-19. EMA okayed drugs from Regeneron-Roche REGN.O ROG.S and Celltrion 091990.KQ last month.

GSK-Vir's sotrovimab has shown to be effective against all mutations of Omicron in lab studies, paving the way for wider use in populations. EMA had already advised on its use to help member states before the EU-wide green light.

Sotrovimab belongs to a class of drugs called monoclonal antibodies which are lab generated proteins meant to mimic the body's natural defences against infections. Regeneron-Roche's similar therapy does not have the same efficacy against Omicron.


The European Union's public health body warned on Wednesday that there was a "very high" risk Omicron would become dominant in Europe by early next year.

Sobi's Kineret is primarily used to treat rheumatoid arthritis as the drug reduces the activity of the immune system and a chemical messenger in the immune process that causes inflammation.

COVID-19 patients with severe symptoms including pneumonia are believed to suffer from an overreaction of the immune system known as cytokine storm, which drugs such as Kineret have shown to control.

Final and formal approvals are up to the European Commission (EC), which typically endorses EMA recommendations. EMA said it would send its advice to the Commission for a "rapid decision".

Other approved COVID-19 treatments in the EU are Regeneron-Roche's antibody cocktail Ronapreve, Celltrion's antibody drug Regkirona, Roche's arthritis drug RoActemra and Gilead's GILD.O antiviral infusion remdesivir.

EMA is also reviewing AstraZeneca's AZN.L antibody cocktail and COVID-19 pills from Merck MRK.N and Pfizer PFE.N .

Omicron set to be Europe's dominant variant by early 2022 - ECDC

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FACTBOX-Front runners in development of antibody drugs against COVID-19

FACTBOX-What COVID-19 vaccine and drug makers have to say about Omicron

Reporting by Pushkala Aripaka and Amna Karimi in Bengaluru; Editing by Edmund Blair

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