Lilly Pulls EU Approval Application For Olumiant In COVID-19

The European Medicines Agency says it does not have enough data to justify the approval of Olumiant for hospitalized COVID-19 patients. The marketing authorization application for another product, Reata’s Imbarkyd for chronic kidney disease, has also been withdrawn.  

Microscopic view of Coronavirus, a pathogen that attacks the respiratory tract. Analysis and test, experimentation. Sars. 3d render
The EMA says it cannot approve Olumiant for COVID-19 at present • Source: Shutterstock

Lilly Nederland BV has withdrawn the EU marketing authorization application (MAA) for its Janus kinase inhibitor, Olumiant (baricitinib), for use in treating adults and children with COVID-19 who require supplemental oxygen, after the European Medicines Agency said the company had not provided enough data for an approval recommendation.

Another product has been also pulled from the EMA review process: Reata Pharmaceuticals, Inc

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