United Kingdom: The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the first product through the International Recognition Procedure (IRP). Since its launch in January 2024, the IRP aims to bring life-saving new treatments to UK patients without delay.
MHRA permitted a new formulation for XGEVA (denosumab), through the IRP. XGEVA is a treatment used in adults to prevent bone-related complications caused by bone metastasis and to treat oversized cell tumours of bone in both adults and adolescents. This marks the first product approved under the new procedure. The treatment was approved in 30 days, providing UK patients with earlier access thanks to international recognition.
The IRP enables the MHRA to speed up the evaluation of new medications by considering the knowledge and decision-making of reliable regulatory partners during the authorization process. That means drugs already approved by strict regulatory authorities in other countries will be made available to UK patients much faster, resulting in a more efficient, cost-effective and time-saving process for pharmaceutical companies.
Denosumab was approved on February 29, 2024, as a 120 milligram solution for injection into a prefilled syringe. This new option will make it more convenient for patients in the UK as it will be provided at a higher concentration, already loaded into a syringe and at the same dose as the current vial presentation. This will simplify the administration process, reduce the volume of liquid injected, and lower the risk of dosing errors.
Trained patients and caregivers can now self-administer the product under healthcare professional supervision for the first time. The product received a positive opinion from the European Medicines Agency’s (EMA), Committee for Medicinal Products for Human Use (CHMP), on 25 January 2024.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, stated that, “We are focused on providing UK patients rapid access to safe and effective medical treatments. 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 underway. We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review.”
Health Minister Andrew Stephenson commented that, “NHS patients should have access to the newest, most effective medicines and treatments without delay. 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 testament to this innovative approach.”
The active ingredient in XGEVA is denosumab, a protein that slows bone destruction caused by bone metastasis or giant cell tumours of bone. The medicine may cause bone, joint, and muscle pain, shortness of breath, diarrhoea, and low calcium levels in the blood.
No new clinical studies are needed for the approval of the new formulation of denosumab in a prefilled syringe as the existing medicine and the new formulation will be used to treat the same conditions at the same dose.
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