Breaking news | MHRA grants first approval via the new IRP in 30 days

Launched in January 2024, IRP aims to further help bring life-saving new medicines to UK patients without delay

Launched in January 2024, IRP aims to further help bring life-saving new medicines to UK patients without delay
March 1, 2024

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.

If you need regulatory help, we can assist you! Our team is well-versed in UK requirements and can provide the guidance you need to navigate regulatory compliance smoothly. Contact us at: info@asphalion.com

Or schedule a free 30-minutes meeting here: FREE MEETING

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | 20th Biosimilar Medicines Conference by MFE

During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.

New opening! | Pamplona office

At Asphalion, we are thrilled to announce the opening of our new office in Pamplona! This strategic decision reflects our commitment to being closer to

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting