MHRA grants first approval via the new International Recognition Procedure in 30 days
Launched in January 2024, IRP aims to further help bring life-saving new medicines to UK patients without delay
A new formulation for XGEVA (denosumab), a treatment used in adults to prevent serious bone-related complications caused by bone metastasis and to treat giant cell tumour of bone in adults and adolescents, is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). The product was authorised in 30 days, providing UK patients with earlier access to this treatment thanks to international recognition.
Launched in January this year, the IRP allows the MHRA to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners in the authorisation process. As a result, medicines that have been approved in other countries with stringent regulators will get to UK patients without delay, resulting in a more rapid, efficient, and cost-effective process for life sciences companies.
Denosumab (XGEVA) was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. This means that UK patients will have access to a more convenient option compared to the current vial presentation, as denosumab will now be provided at the same dose but in a higher concentration, already loaded in a syringe. This simplifies the administration process, reduces the volume of liquid injected, and lowers the risk of dosing errors.
Patients and caregivers who have been trained in injection techniques by a healthcare professional can now administer the product. The first self-administration should be supervised by a healthcare professional.
The product was initially reviewed by the European Medicines Agency (EMA) and received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 25 January 2024. The MHRA considered the assessment made by the European regulator as part of its own review, facilitating a rapid approval process.
IRP is open to applicants that have already received an authorisation for the same product from one of MHRA’s specified trusted regulators. These are the regulatory authorities from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States.
As a sovereign regulator, the MHRA retains ultimate authority to accept or reject applications submitted under the IRP, ensuring that all products meet safety, quality and effectiveness standards to be licensed in the UK.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
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 under way.
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 said:
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.
How the medicine works
The active ingredient in XGEVA, denosumab, is a protein that works to slow down bone destruction caused by cancer spreading to the bone (bone metastasis) or by giant cell tumour of bone.
Evidence base
This approval is supported by acceptable evidence of the quality of the new formulation of denosumab in a prefilled syringe, including manufacturing, release testing and shelf-life. Since the new formulation will be used to treat the same conditions as the existing medicine at the same dose, no new clinical studies needed to be conducted.
Side effects
The most common side effects of the medicine (which may affect more than 1 in 10 people) include bone, joint and/or muscle pain which is sometimes severe, shortness of breath, diarrhoea, and low calcium levels in the blood.
As with any medicine, the MHRA will keep the safety and effectiveness of XGEVA under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
- Applications under International Recognition Procedure (IRP) can be received via the MHRA website. Time horizons for authorisations are set at 60 to 110 days – considerably shorter than the current 150-day time horizon for applications. To further streamline the IRP application process, the MHRA launched an ‘Eligibility Checker’ tool on 20 November 2023.
- The new marketing authorisation was granted on 29 February 2024 to Amgen Limited. This was a line extension of the original marketing authorisation for XGEVA 120 mg solution for injection which was granted on 13 July 2011 and is provided in vials.
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- Patients diagnosed with tumours (cancer) that have spread to the bones (bone metastases) face significant risks of bone-related complications. These complications, known as skeletal-related events, include bone fractures, spinal cord compression, and the need for radiation therapy or bone surgery.
- Giant cell tumours of bone are rare benign (non-cancerous) tumours that mostly occur in the long bones found in the arms and legs and can severely damage the bones.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.