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Amgen Wins First Approval Through UK’s New International Recognition Procedure

 
• By Eliza Slawther

The UK MHRA approved a new version of Amgen’s established bone cancer complication drug Xgeva based on a review conducted by the European Medicines Agency.

Approved stamp

A line extension for Amgen’s Xgeva (denosumab) was granted by the UK’s Medicines and Healthcare products Regulatory Agency using its newly-launched International Recognition Procedure (IRP), marking the first authorization made under the scheme.

The extension for Xgeva, a treatment for bone-related complications caused by bone cancer that was first approved in 2011, will...

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