MHRA awards Innovation Passports to Huntington's, Alzheimer's and lung cancer treatments
Three experimental medicines from Alnylam, BeOne Medicines and Biogen have entered the UK's Innovative Licensing and Access Pathway, which brings the regulator, NICE and the NHS into development early. The next application round runs to 11 February 2027.
By Daily Oracles News Team2 min read
Three medicines still in clinical development, for Huntington's disease, early Alzheimer's disease and non-small cell lung cancer, have been given Innovation Passports by the Medicines and Healthcare products Regulatory Agency (MHRA).
The passport is the way into the Innovative Licensing and Access Pathway (ILAP), under which a developer works with the regulator, the health technology assessment bodies and the NHS from the early stages of clinical development. The MHRA says the aim is to cut the time between research and a medicine reaching patients. The ILAP Selection Panel chose the three products.
The MHRA stressed that all three remain in development and that whether they become available will depend on the evidence of their safety, effectiveness and value.
The three medicines
Brezosiran (Alnylam). A small interfering RNA, a molecule that silences a gene by cutting its messenger RNA, for Huntington's disease. Huntington's is a rare, inherited neurodegenerative condition that is ultimately fatal. Alnylam said there are no approved therapies that slow its progression.
BGB-58067 (BeOne Medicines). A small-molecule cancer drug whose lead use is expected to be first-line treatment of non-small cell lung cancer, the form behind around 80 to 85% of lung cancers. BeOne said it is aimed at patients with MTAP-deficient tumours, for whom no targeted therapies are available, and that it is the company's second investigational medicine to enter the pathway in recent months. Around 50,200 people are diagnosed with lung cancer in the UK each year.
Diranersen (Biogen). An antisense oligonucleotide for early Alzheimer's disease, the most common cause of dementia. An estimated 982,000 people in the UK were living with dementia in 2024.
The pathway partners
ILAP is a UK-wide partnership between the MHRA, NHS England, the National Institute for Health and Care Excellence, the Scottish Medicines Consortium, the All Wales Therapeutics and Toxicology Centre and the Department of Health in Northern Ireland. It is open to commercial and non-commercial developers anywhere in the world, provided the product has a therapeutic aim, there is evidence of safe use in people and confirmatory trials have not yet started.
The next round of Innovation Passport applications opened on Monday 9 November and closes on 11 February 2027.
