Xgeva first drug approved under MHRA’s IRP
A new formulation of Xgeva (denosumab) is the first product to be authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) via the regulator’s new International Recognition Procedure (IRP).
Amgen’s (Nasdaq: AMGN) product is used for preventing serious bone-related complications caused by bone metastasis and treating giant cell tumor of bone.
"This new international agreement allows treatments to be approved more quickly by drawing on expertise from partners across the world"The product was authorized in 30 days, providing UK patients with earlier access to this treatment thanks to international recognition.
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