LONDON, Aug. 4 -- The government of the United Kingdom issued the following news:
Twonewmedicinesin development that could become effective therapies for patients in the future havebeen granted Innovation Passports (IP) through the UK'sInnovative Licensing and Access Pathway(ILAP).
Innovation Passport designation is awarded to products thatcouldaddress unmet clinical need and show potential to deliver significant benefits for patients.TheILAPis delivered through a partnership between theMedicines and Healthcare products Regulatory Agency (MHRA),NHSEngland,the UK Health Technology Assessment(HTA)bodies - the National Institute for Health and Care Excellence (NICE),theScottish Medicines Consortium (SMC) theAll WalesTherapeutics and Toxicology Centre (AWTTC), and the Department of Health Northern Ireland.
Following assessment by the ILAP Selection Panel, an IPhas been awarded to:
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A biological medicine forhepatocellularcarcinoma(liver cancer)
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A small-molecule medicine fordementiawith Lewybodies
There are around 7,000 new liver cancer cases in the UK each year and hepatocellular carcinoma is the mostcommon form.Dementiawith Lewybodiesis a progressive and complex neurological conditionthatimpactsaround three in twenty dementia patients andtreatment optionsremainlimited.
ThesenewIPsdemonstratethebreadth of innovationthatissupported through the ILAP and highlights the programme's role in accelerating the development of potentially transformative medicines across a wide range oftherapeuticareas.
The InnovationPassportenables developers to access a range ofservicesand enhanced regulatory and market access guidance through a coordinated pathway, designed to support the development of innovative medicines that address unmet patient needs.
The ILAPfacilitatesearly and ongoing interaction with the MHRA, the HTA bodies and the NHSbyofferingamore efficient and joined-upengagementto help speed up access for patients.
The productsawarded an IPare still in development, and any future availability will depend on the evidence of safety,effectivenessand value.
Companies developing innovative medicines that address unmet patient needs across all therapeutic areas are encouraged to review the eligibility criteria andsubmitan application.Full guidance is available on theMHRA website.
Applications forthenextILAPround opentoday (4 August 2026)and remain open until 4 November 2026.
James Pound,MHRA Executive Director, Innovation and Compliance,said:
"These latest Innovation Passport awards demonstrate the breadth and ambition of the Innovative Licensing and Access Pathway.
"By supporting innovative medicines across a diverse range of therapeutic areas, the ILAP helps developers engage with the regulatory system earlier and more effectively, with theultimate goalof enabling earlier patient access to innovative new treatments.
"We are delighted to recognise these two innovative products and look forward to supporting their development through the pathway."
John Spoors, Programme Director for Commercial, Managedaccessand Medicines Policy at NICE said:
"We welcome the announcement that these two medicines have been granted Innovation Passports through the Innovative Licensing and Access Pathway. As an organisation committed to getting the best care to people fast, NICE welcomes the opportunity, through ILAP, to work with developers and partners across the health system to support evidence generation and early engagement on the issues that will shape future evaluation and patient access."
Sarah Knight, Senior Commercial Lead at NHS England, said:
"These Innovation Passport awards recognise promising new medicines in development that have the potential tobenefit people living with liver cancer and dementia, who have limited treatment options.
"Through this innovative programme, NHS England is helping to provide pharmaceutical companies with earlier, joined-up advice and support, helping to fast-track drug development so treatments that prove safe, effective and good value can get to the people who need them sooner."
Dr Rob Peel, chair of the Scottish Medicines Consortium, said:
"The Scottish Medicines Consortium, as part of Healthcare Improvement Scotland, is pleased to see two more products enter the ILAP. Liver cancer is a devastating diagnosis for patients. The impact of dementia with Lewy bodies on patients and their families is far-reaching. We look forward to working with developers for these two products."
Dr Andrew Champion, AWTTC Programme Director, said:
"The latest Innovation Passports awarded through the Innovative Licensing and Access Pathway highlight the value and purpose of the process in supporting assessment of innovative medicines for patients with significant unmet clinical needs.AWTTC is proud to work alongside our UK partners to help improve access to promising new medicines that willultimately benefitpatients in Wales and across the UK."
James Harris, Interim General Manager,BeOneMedicines UK & Ireland Ltd.said:
"Patients with hepatocellular carcinoma continue to face a poor prognosis, underscoring the urgent need for new treatment options."
"We believe BGB-B2033 has the potential to make a meaningful difference for this patient population, and wewelcome the opportunity toparticipateinthe UK's Innovative Licensing and Access Pathway, which promotes early collaboration to accelerate patient access to potentially transformative medicines. We look forward to working closely with the MHRA and ILAP partners as we advance the development of this investigational medicine."
Dr. John Alam, CEO,CervoMed, said:
"We're grateful thatCervoMed'sinvestigational treatment,neflamapimod, willbenefitfrom the integrated support provided by ILAP. The UK has been a global leader in research that has advanced the understanding and management of Dementia with Lewy bodies. With this designation, the UK government furtherdemonstratesits conviction to accelerate access to treatments such asneflamapimodthat have the potential to be a "step change" in the management of the estimated approximately 100,000 people in the UK living with this devastating disease. We look forward to the collaboration with UK regulators, HTA bodies, and NHS partners and work with those groups towards early alignment in the regulatory and reimbursement review process."
Notes to editors:
Entry to ILAP is open to commercial and non-commercial developers worldwide. Applicants mustsubmitmedicines or drug-device combinations that have not yet entered their confirmatory trial, which will give more opportunity tobenefitfrom the support offered within the pathway. More details can be found on theMHRA website.
The ILAP is a UK-wide initiative,comprisingthe following partners:
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The All Wales Therapeutics and Toxicology Centre (AWTTC)(on behalf of NHS Health boards and Trusts in Wales)
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The Medicines and Healthcare products Regulatory Agency (MHRA)
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National Institute for Health and Care Excellence (NICE)
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NHS England
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Scottish Medicines Consortium (SMC)(on behalf of NHS boards in Scotland)
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Department of Health Northern Ireland
Supporting partners include:
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Department of Health and Social Care (DHSC)
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National Institute for Health Research (NIHR)
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Office for Life Sciences (OLS)
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Scottish Government
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Welsh Government
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Recently published articlesthatprovide information on the benefit of theILAP Target Development Profileand howthe ILAP and the MHRA-NICE Aligned Pathway work together.
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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.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.
