EU Evaluates Sobi Arthritis Drug to Treat COVID-19 with Pneumonia
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Europe's medicines regulator is evaluating an application to use an arthritis drug developed by Sweden's Sobi (SOBIV.ST) to treat COVID-19 in adults with pneumonia who are at risk of severe respiratory failure, the agency said on Monday.
The rheumatoid arthritis drug, Kineret, is the latest possible COVID-19 treatment to be reviewed by the European Medicines Agency (EMA) as the more infectious Delta variant of the coronavirus spurs an increase in cases.
Gilead's (GILD.O) remdesivir is the only drug currently authorized for COVID-19 treatment in the European Union.
Kineret and its active substance anakinra reduce the activity of the immune system and a chemical messenger in the immune process that causes inflammation.
"It is thought that this could also help reduce the inflammation and tissue damage associated with COVID-19," the EMA said in a statement.
Kineret is the second rheumatoid arthritis drug to be reviewed by the EMA for COVID-19 use following U.S.-based Lilly's (LLY.N) application for Olumiant as a treatment for hospitalized COVID-19 patients receiving oxygen.
A small retrospective study from Italy last year showed that treatment with anakinra appears to have improved respiratory symptoms and reduced signs of cytokine storm in nearly three-quarters of patients with COVID-19, acute respiratory distress, and hyperinflammation.
COVID-19 patients with severe symptoms including pneumonia are believed to suffer from an overreaction of the immune system known as cytokine storm.
The regulator said on Monday it will assess data including results from two ongoing clinical studies investigating the safety and efficacy of Kineret in patients hospitalized with COVID-19. It expects the outcome of the evaluation in October.
Other treatments under rolling review in the EU include antibodies or antibody cocktails developed by Lilly, Celltrion (068270.KS), and Regeneron (REGN.O), and one jointly developed by GlaxoSmithKline (GSK.L) and Vir Biotechnology (VIR.O).
The regulator has backed the use of some of the therapies while the rolling review, aimed to speed up the process of approval by allowing researchers to submit findings in real-time, is still ongoing.