UK's Innovative Licensing and Access Pathway awards Innovation Passports to two investigational liver cancer and dementia medicines

Two investigational medicines targeting liver cancer and dementia with Lewy bodies have been granted Innovation Passports through the UK's Innovative Licensing and Access Pathway, providing developers with coordinated regulatory and health technology assessment support during clinical development.

The Baseline

• The latest Innovation Passport awards bring one investigational medicine for liver cancer and another for dementia with Lewy bodies into the UK’s Innovative Licensing and Access Pathway.
• Innovation Passport designation provides developers with coordinated support from the Medicines and Healthcare products Regulatory Agency, NHS England, and UK HTA bodies to help accelerate development and patient access.
• ILAP is designed to support evidence generation and streamline regulatory and reimbursement pathways for medicines that address significant unmet clinical need.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that Innovation Passports have been awarded to two investigational medicines in recognition of their potential to address unmet clinical needs. Following assessment by the Innovative Licensing and Access Pathway (ILAP) Selection Panel, the Innovation Passports were granted to BeOne Medicines’s biological medicine for hepatocellular carcinoma and CervoMed’s small molecule medicine for dementia with Lewy bodies.

Innovation Passport designation is awarded to medicines in development that have the potential to deliver significant patient benefit while addressing unmet clinical need. Through ILAP, developers receive coordinated regulatory, health technology assessment (HTA), and NHS guidance from 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 pathway is intended to support evidence generation and encourage earlier alignment on issues that may influence future regulatory, reimbursement, and access decisions.

Sarah Knight, Senior Commercial Lead at NHS England, said the awards recognize "promising new medicines in development that have the potential to benefit people living with liver cancer and dementia, who have limited treatment options." She added that the program provides 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."

James Pound, Executive Director of Innovation and Compliance at the MHRA, 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 the ultimate goal of enabling earlier patient access to innovative new treatments."

John Spoors, Programme Director for Commercial, Managed Access and Medicines Policy at NICE, added that the pathway supports evidence generation and early engagement "on the issues that will shape future evaluation and patient access."

The companies developing the two investigational medicines also welcomed the designations. With around 7000 new cases of liver cancer diagnosed in the UK each year, hepatocellular carcinoma remains an area of significant unmet need. James Harris, Interim General Manager of BeOne Medicines UK & Ireland Ltd, said patients with the disease continue to face "a poor prognosis," highlighting the need for new treatment options.

Similarly, dementia with Lewy bodies affects around three in 20 people living with dementia, yet treatment options remain limited. Dr John Alam, CEO of CervoMed, said the company welcomed the integrated support provided through ILAP, adding that the designation demonstrates the UK's commitment to accelerating access to treatments such as neflamapimod that have the potential to be "a 'step change' in the management" of dementia with Lewy bodies.

Both medicines remain in development, and any future availability will depend on evidence demonstrating their safety, effectiveness, and value. The next ILAP application round opened on August 4, 2026 and will remain open until November 4, 2026.