MHRA awards Innovation Passports to liver cancer and dementia medicines

pharmafile | August 7, 2026 | News story | |  Innovation Passports, MHRA, liver cancer 

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that two investigational medicines targeting liver cancer and dementia with Lewy bodies have been granted Innovation Passport designation through the UK’s Innovative Licensing and Access Pathway (ILAP).

The designations have been awarded to a biological medicine for hepatocellular carcinoma, the most common form of liver cancer, and a small-molecule therapy for dementia with Lewy bodies. Both conditions have significant unmet clinical need and limited treatment options.

Innovation Passport status is granted to medicines considered to have the potential to deliver substantial benefits for patients. It enables developers to access coordinated regulatory and health technology assessment support aimed at accelerating the development and evaluation of promising therapies.

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Around 7,000 people are diagnosed with liver cancer each year in the UK, while dementia with Lewy bodies accounts for an estimated 15% of dementia cases.

The ILAP programme brings together 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 to provide earlier and more coordinated engagement throughout medicine development.

The MHRA said the latest awards demonstrate the breadth of innovation supported through the pathway, spanning therapeutic areas where patients continue to face significant unmet clinical need.

Medicines granted an Innovation Passport remain in clinical development and must still demonstrate safety, efficacy and value before they can be approved for routine use.

Applications for the next ILAP assessment round remain open until 4 November 2026.

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