LEO Pharma A/S's celebrations at getting the European Medicines Agency's backing for tralokinumab last week have ground to an abrupt halt after regulators in the US rejected the Danish group's biologics license application for the atopic dermatitis therapy touted as a serious rival to Sanofi and Regeneron Pharmaceuticals, Inc.'s blockbuster Dupixent.
The US Food and Drug Administration has issued a complete response letter requesting additional data relating to a device component of tralokinumab, an interleukin-13 blocker which is injected subcutaneously
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