MHRA Grants Innovation Passports for Investigational Lung Cancer, Huntington's, and Alzheimer's Drugs
On 9 November 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that three experimental drugs received Innovation Passports through the UK's Innovative Licensing and Access Pathway (ILAP). The selected drugs target non-small cell lung cancer, Huntington's disease, and early Alzheimer's disease. This passport allows drug developers to work directly with regulatory, health assessment, and NHS bodies while their therapies are still in early clinical development. The treatments include brezosiran from Alnylam for Huntington's disease, BGB-58067 from BeOne Medicines for non-small cell lung cancer, and diranersen from Biogen for early Alzheimer's disease. Non-small cell lung cancer accounts for 80 to 85 percent of the roughly 50,200 lung cancer cases diagnosed each year in the UK. Meanwhile, about 982,000 people were living with dementia in the UK in 2024. These investigational therapies are still undergoing testing, so future availability depends on proving safety, effectiveness, and value.
What was announced
The Medicines and Healthcare products Regulatory Agency (MHRA) awarded Innovation Passports to three investigational therapies on 9 November 2026. The awards were made through the UK's Innovative Licensing and Access Pathway.
The three therapies are:
- Brezosiran, an investigational RNA interference treatment developed by Alnylam for Huntington's disease.
- BGB-58067, a small molecule PRMT5 inhibitor developed by BeOne Medicines UK & Ireland Ltd for non-small cell lung cancer, specifically focused on MTAP-deficient tumours.
- Diranersen, an antisense oligonucleotide developed by Biogen UK & Ireland for early Alzheimer's disease.
The MHRA also confirmed that applications for the next round of Innovation Passports opened on 9 November 2026 and will close on 11 February 2027.
What it means
Entry into the pathway allows medicine developers to coordinate early with several UK healthcare agencies. These partners include the MHRA, National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC), All Wales Therapeutics and Toxicology Centre (AWTTC), NHS England, and the Department of Health Northern Ireland.
Developers enter the programme before starting their confirmatory clinical trials. This early entry helps companies generate required evidence on safety, effectiveness, and financial value alongside regulatory bodies. The goal of the pathway is to reduce product development risks and speed up potential access for patients across the UK.
What the announcement does not tell us
The announcement does not state when clinical trials for any of the three treatments will conclude. It does not provide specific timelines for when patients in the UK might access these drugs if approved.
The release leaves out details regarding expected treatment costs, manufacturing locations, or specific trial results. Furthermore, the agency does not specify how many total applications were submitted for this round of Innovation Passports or why other candidate drugs were not selected.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is gov.uk: Medicines and Healthcare products Regulatory Agency’s own. Always check the original before acting on anything here.
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 (MH…
Opens www.gov.uk
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