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Three investigational medicines have been given Innovation Passports, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on 9 November 2026. The treatments target Huntington's disease, early Alzheimer's disease and non small cell lung cancer, and all three are still in development.
The passports open the door to the Innovative Licensing and Access Pathway, known as ILAP, which lets developers work with the regulator, the NHS and the bodies that assess value for money from an early stage. The MHRA stresses that none of the products is yet available, and that any future access depends on evidence of safety, effectiveness and value.
At a Glance
- The MHRA has awarded Innovation Passports to three investigational treatments for Huntington's disease, early Alzheimer's disease and non small cell lung cancer.
- An Innovation Passport gives developers coordinated support through the Innovative Licensing and Access Pathway, which the MHRA describes as the only end to end access pathway of its kind in the world.
- Applications for the next round of Innovation Passports opened on 9 November 2026 and close on 11 February 2027.
- Non small cell lung cancer accounts for around 80 to 85 per cent of lung cancer cases, and around 50,200 people are diagnosed with lung cancer in the UK each year.
- The products remain in development, and the government says any future availability will depend on evidence of safety, effectiveness and value.
Which treatments have been awarded an Innovation Passport?
The ILAP Selection Panel assessed the applications and chose three. The first is a chemical siRNA, a small interfering RNA designed to silence genes by cleaving messenger RNA, being developed for Huntington's disease. The second is a chemical small molecule oncology therapy, with first line non small cell lung cancer (NSCLC) expected to be its lead indication. The third is a chemical antisense oligonucleotide, or ASO, for early Alzheimer's disease.
The announcement does not name the products, but the companies behind them did so in their statements. Alnylam said its investigational RNAi therapeutic, brezosiran, had received a passport for Huntington's disease. BeOne Medicines UK & Ireland said the award covered BGB-58067, an investigational PRMT5 inhibitor for NSCLC. Biogen UK & Ireland welcomed the designation for diranersen in Alzheimer's disease.
Each condition carries a heavy burden. Huntington's disease is rare, inherited and ultimately fatal, and places a substantial load on patients and their families. Alzheimer's is a progressive neurodegenerative disorder and the most common cause of dementia, with an estimated 982,000 people living with dementia in the UK in 2024. That number is expected to rise.
What is the Innovative Licensing and Access Pathway (ILAP)?
The ILAP is designed to reduce the risk in product development and speed up patient access to new medicines and drug device combinations. It does that by putting developers, the regulator, NHS bodies and health technology assessment organisations on a single integrated platform, so questions about evidence and access can be raised early rather than at the end.
The partnership is UK wide. Its core members are the MHRA, NHS England, 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. The Department of Health and Social Care, the National Institute for Health Research, the Office for Life Sciences, the Scottish Government and the Welsh Government act as supporting partners.
Entry is open to commercial and non-commercial developers anywhere in the world. There is one important condition, applicants must submit medicines or drug device combinations that have not yet entered their confirmatory trial. The earlier the product joins, the more of the pathway's support it can use.
Applying for the next round of Innovation Passports
- Applications for the next round opened on 9 November 2026.
- The window remains open until 11 February 2027.
- Entry is open to commercial and non-commercial developers worldwide.
- The medicine or drug device combination must not yet have entered its confirmatory trial.
What does an Innovation Passport mean for patients?
A passport is a development milestone, not a licence. The MHRA says the three products "show real promise" in addressing unmet needs, according to its Chief Medical and Scientific Officer, Professor Jacob George. But the agency is also clear that these are investigational treatments. Whether any of them reaches patients will turn on the evidence that trials produce.
What the passport provides
- Coordinated support through the ILAP throughout development.
- Early engagement with the MHRA, NHS bodies and health technology assessment organisations.
- A route for developers to plan evidence generation for future evaluation.
What the passport does not provide
- It is not marketing authorisation for any of the three products.
- It does not guarantee NHS availability.
- It does not replace the need for evidence of safety, effectiveness and value.
The announcement gives no timetable for when any of the three products might complete development. It also does not say how many patients could benefit or how much public money is involved.
What NICE, the MHRA and drug makers said about the Innovation Passports
John Spoors, Deputy Director of Medicines Evaluation at NICE, said the organisation welcomed the chance, through ILAP, to work with developers and partners on evidence generation and early engagement on the issues that will shape future evaluation and access. The SMC's chair, Dr Rob Peel, said it was encouraging to see innovation directed towards areas of important unmet need.
Dr Andrew Champion, AWTTC Programme Director, described the awards as an encouraging step and said the centre would bring the needs of patients and NHS Wales into the process. The shared ambition, he said, is to help promising medicines reach patients in Wales and across the UK, supported by robust evidence of safety, effectiveness and value.
The company statements were more specific. Alnylam's chief executive, Yvonne Greenstreet, said Huntington's disease has no approved therapies to slow its progression. BeOne's James Harris pointed to patients with MTAP deficient lung tumours, for whom he said no targeted therapies are currently available, and noted this was the second BeOne investigational medicine to enter ILAP in recent months. Biogen UK & Ireland's managing director, Dr Kylie Bromley, called Alzheimer's one of the greatest health and social care challenges of our time.
What happens next for the three medicines?
For the three passport holders, the next stage is working with the MHRA and ILAP partners as development continues. The MHRA has not set out milestones for any of them, and the products will need to clear the usual regulatory and assessment hurdles before they could be offered on the NHS.
For other developers, the clock is already running. The next application round closes on 11 February 2027, and the MHRA is encouraging companies working on medicines for unmet patient need, in any therapeutic area, to check the eligibility criteria and apply. Full guidance sits on the MHRA website.
Key Takeaways
- The MHRA announced on 9 November 2026 that three investigational treatments for Huntington's disease, early Alzheimer's disease and non small cell lung cancer have won Innovation Passports.
- The passports give developers coordinated support from the MHRA, NHS England, NICE, the Scottish Medicines Consortium, AWTTC and the Department of Health Northern Ireland.
- None of the three products is approved, and any future availability will depend on evidence of safety, effectiveness and value.
- The companies named in connection with the awards are Alnylam, BeOne Medicines and Biogen.
- Applications for the next round of Innovation Passports are open until 11 February 2027 and require that a product has not yet entered its confirmatory trial.