The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for a new formulation of Amgen’s XGEVA (denosumab) to prevent serious bone-related complications.
This development marks the first product approved by the MHRA through the International Recognition Procedure (IRP) launched in 2024.
XGEVA’s new formulation, a 120mg solution for injection in a prefilled syringe, is intended for adult and adolescent patients with bone metastases and treating giant cells in bone tumours.
The approval of the new denosumab formulation comes with evidence supporting its quality, including aspects of manufacturing, release testing and shelf-life.
As the treatment indications and dosages remain unchanged, no additional clinical studies were required.
The IRP enabled the UK regulator to expedite the new medicine evaluation by integrating the expertise and decisions of other trusted regulatory partners.
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This approach ensures that treatments approved by stringent regulators abroad can reach UK patients more promptly, benefiting both patients and the life sciences sector.
This streamlined process led to the granting of authorisation for the formulation of XGEVA within 30 days.
The prefilled syringes will offer UK patients a more convenient administration option compared to the previous vial presentation, with a higher concentration of the medication preloaded in the syringe, reducing injection volume and the potential for dosing errors.
The European Medicines Agency (EMA) reviewed the product and the Committee for Medicinal Products for Human Use issued a positive opinion in early 2024.
The MHRA considered the EMA’s assessment as part of its review process and granted rapid approval.
UK Health Minister Andrew Stephenson stated: “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.”
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