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.
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