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The Medicines and Healthcare products Regulatory Agency (MHRA) has on Friday approved leniolisib phosphate (Joenja) to treat a rare immune disease known as activated phosphoinositide 3-kinase delta syndrome or APDS in adults and adolescents aged 12-years-old and older who weigh 45kg or more. The medicine was approved via a fast-track approval process for medicines, known as the International Recognition Procedure (IRP), which allows the MHRA to consider the expertise and decision-making of trusted regulatory partners for the benefit of UK patients. The decision follows an approval for the drug by the US Food and Drug Administration (FDA). This is the first time the MHRA has approved a new medicine following FDA approval. The MHRA said it considered the assessment made by the US regulator as part of its own review, facilitating a rapid approval process. APDS is an inherited disorder where the patient is unable to fight infections because the immune system does not work properly. The main symptoms usually occur in the first two years of life and include repeated lung infections and a failure to grow and develop normally.

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new tool to check the eligibility for marketing authorisation applicants. Applicants are now required to use the online 'Eligibility Checker' tool to determine whether their Marketing Authorisation Application (MAA) is suitable for the Agency's International Recognition procedure (IRP), which will become operational on 1 January 2024. The tool will also help applicants identify which route (A or B) to follow, before submitting their IRP application. Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said that the tool has been tailored to "facilitate a smooth and efficient process for marketing authorisation applicants."

The Medicines and Healthcare products Regulatory Agency (MHRA) made its new International Recognition procedure (IRP) fully operational from 1 January 2024, inviting developers of new medicines to submit their applications for marketing authorisation. Beginning this year, the EC Decision Reliance Procedure (ECDRP) has been replaced by IRP, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has come under its umbrella. The move is expected to further improve access to life-saving medicines for UK patients following the UK's departure from the European Union.

The latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis. It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both adults and adolescents. The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors. The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.