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FDA Thwarts Leo Pharma's US Launch Plans For Tralokinumab

Agency Issues CRL For Atopic Dermatitis Drug

 
• By Kevin Grogan

A week after getting the thumbs-up from the CHMP for tralokinumab, the Denmark-based dermatology specialist has been hit by a complete response letter from US regulators requesting more data about a device component of the IL-13 inhibitor.

Rhino
Tralokinumab path to approval blocked • Source: Alamy

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.

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