MHRA approves first drug via the new IRP in 30 days

The latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis.

It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP).

Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both
adults and adolescents.

The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this
simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors.

The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.