MHRA approves first drug via the new IRP in 30 days

XGEVA is the first product to be authorised by the regulator through the new International Recognition Procedure (IRP).

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.

“NHS patients should have access to the newest, most effective medicines and treatments without delay,” said Health Minister Andrew Stephenson.

“This new international agreement allows treatments to be approved more quickly by drawing on expertise from partners across the world, reducing bureaucracy and sharing resources so patients can benefit as soon as possible.

“XGEVA being approved quicker than usual is a testament to this innovative approach,” she added.

The European Medicines Agency (EMA) initially evaluated XGEVA, and on 25 January 2024, the EMA's Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion.

The MHRA incorporated this assessment from the European regulator into its own review process.

“I’m very pleased to announce that we have granted the first approval through IRP in 30 days, demonstrating that this new process for bringing new medicines to UK patients is well under way,” said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

She assured that “appropriate regulatory standards” for the approval of this medicine have been met.

Denosumab, the active component in XGEVA, is a protein designed to decelerate bone destruction caused by the spread of cancer to the bone (bone metastasis) or by giant cell tumour of bone.

The IRP was launched in January this year, allowing the MHRA to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners.

However, the MHRA retains ultimate authority to accept or reject applications submitted under the IRP.