Investigational treatments for lung cancer, Huntington’s disease and Alzheimer's gain Innovation Passports through the Innovative Licensing and Access Pathway
Three innovative medicines with the potential to meet unmet needs in lung cancer, Huntington’s disease and Alzheimer’s disease have been given Innovation Passports, the Medicines and Healthcare products Regulatory Agency (MHRA) announced today.
This means they can access coordinated support throughout development through the UK’s Innovative Licensing and Access Pathway (ILAP). This is the only end-to-end access pathway in the world where developers can work, from early stages of clinical development, with the national health system, the regulator and health technology assessment bodies.
The ILAP is designed to de-risk product development and accelerate patient access to transformative new medicines and drug-device combinations, by providing a single integrated platform for collaboration.
Following assessment by the ILAP Selection Panel, Innovation Passports have been awarded to:
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A chemical siRNA (small interfering RNA that can silence genes by cleaving mRNA) for the treatment of Huntington’s disease
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A chemical small molecule oncology therapy, with first-line Non-Small Cell Lung Cancer (NSCLC) expected to be the lead indication.
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A chemical Antisense Oligonucleotide (ASO) for the treatment of early Alzheimer’s disease
Huntington’s disease is a rare, inherited and ultimately fatal neurodegenerative disease that places substantial burden on those affected and their families.
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for around 80–85% of cases. Around 50,200 people are diagnosed with lung cancer in the UK each year.
Alzheimer’s disease is a progressive neurodegenerative disorder and the most common cause of dementia. An estimated 982,000 people were living with dementia in the UK in 2024, with the number expected to rise.
Professor Jacob George, Chief Medical and Scientific Officer of the Medicines and Healthcare products Regulatory Agency said:
The Innovative Licensing and Access Pathway is a globally unique initiative designed to accelerate patient access to transformative new medicines and drug-device combinations.
Today, we have issued Innovation Passports to three therapies that show real promise in addressing the unmet needs in Alzheimer’s, lung cancer and Huntington’s disease.
John Spoors, Deputy Director of Medicines Evaluation at NICE said:
We welcome the announcement that these medicines have been granted Innovation Passports through the Innovative Licensing and Access Pathway. 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.
Dr Rob Peel, chair of the Scottish Medicines Consortium, said:
We are pleased to support the Innovative Licensing and Access Pathway in recognising promising new therapies for Huntington’s disease, Alzheimer’s disease and lung cancer. These conditions continue to place a substantial burden on patients, families and healthcare systems, and it is encouraging to see innovation being directed towards areas of important unmet need.
Dr Andrew Champion, AWTTC Programme Director, said:
The award of Innovation Passports to these three investigational treatments is an encouraging step towards addressing unmet needs in lung cancer, Huntington’s disease and Alzheimer’s disease. AWTTC is pleased to work alongside our UK partners to support their development and assessment, bringing the needs of patients and NHS Wales into this collaborative process. Our shared ambition is to help promising medicines reach patients in Wales and across the UK, supported by robust evidence of safety, effectiveness and value.
Yvonne Greenstreet, M.D., Chief Executive Officer of Alnylam, said:
Huntington’s disease is a devastating condition with no therapies approved to slow its progression, underscoring the urgent need for new treatment options. We are honored that our investigational RNAi therapeutic brezosiran has received an Innovation Passport and welcome the opportunity to work closely with the MHRA and ILAP partners as we advance its development. We look forward to collaborating through this pathway to advance brezosiran efficiently, with the hope of meaningfully improving the lives of people living with Huntington’s disease.
James Harris, Interim General Manager, BeOne Medicines UK & Ireland Ltd., said:
Despite advances in the treatment of non-small cell lung cancer, significant unmet needs remain, particularly for patients with MTAP-deficient tumours, for whom no targeted therapies are currently available. The award of an Innovation Passport for BGB-58067 marks the second BeOne investigational medicine to enter the UK’s Innovative Licensing and Access Pathway in recent months, reflecting the strength of our oncology pipeline and our commitment to translating scientific innovation into potential new treatment options for patients who urgently need them.
We welcome the opportunity to work closely with the MHRA and ILAP partners as we advance the development of this investigational PRMT5 inhibitor and its potential to bring an innovative new treatment option to patients with non-small cell lung cancer.
Dr Kylie Bromley, Managing Director, Biogen UK & Ireland said:
Alzheimer’s disease remains one of the greatest health and social care challenges of our time and we welcome the MHRA’s Innovation Passport designation for diranersen. We now have an opportunity to collaborate with partners across the health system to ensure that innovations reach the patients who need them. This achievement reinforces our optimism for the future of innovation in Alzheimer’s disease.
The products awarded an Innovation Passport are still in development, and any future availability will depend on the evidence of safety, effectiveness and value.
Companies developing innovative medicines that address unmet patient needs across all therapeutic areas are encouraged to review the eligibility criteria and submit an application. Full guidance is available on the MHRA website.
Applications for the next round of Innovation Passports open today (9 November) and remain open until 11 February 2027.
Notes to editors:
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The ILAP is delivered through a partnership between the Medicines and Healthcare products Regulatory Agency (MHRA), NHS England, the UK Health Technology Assessment (HTA) bodies – the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) the All Wales Therapeutics and Toxicology Centre (AWTTC), and the Department of Health Northern Ireland.
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Entry to ILAP is open to commercial and non-commercial developers worldwide. Applicants must submit medicines or drug-device combinations that have not yet entered their confirmatory trial, which will give more opportunity to benefit from the support offered within the pathway. More details can be found on the MHRA website.
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The ILAP is a UK-wide initiative, comprising the 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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Scottish Medicines Consortium (SMC) (on behalf of NHS boards in Scotland)
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Department of Health Northern Ireland
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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 articles that provide information on the benefit of the ILAP Target Development Profile and how the 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.