MHRA Innovation Passports: three UK drug projects gain development support

10 South Colonnade and Canary Wharf DLR station, London, photographed on 1 March 2014; archive view of the building now listed as MHRA’s address.

Three drug projects have received MHRA Innovation Passports, opening access to coordinated UK support as their developers work towards evidence needed for possible future treatment. The regulator’s announcement on 9 November 2026 covers two RNA-related approaches and an investigational cancer medicine.

For patients and families in Brighton, Hove and across the UK, the distinction is essential: these are medicines in development. Today’s decision does not mean they have been approved, can be prescribed routinely or will be funded by the NHS.

What the MHRA Innovation Passports cover

The MHRA’s original announcement identifies three approaches. Alnylam’s brezosiran is an investigational RNA interference treatment for Huntington’s disease. The regulator describes this category as small interfering RNA, or siRNA, which can silence genes by cleaving messenger RNA.

Biogen’s diranersen is an antisense oligonucleotide, or ASO, being developed for early Alzheimer’s disease. BeOne Medicines’ BGB-58067 is an investigational small-molecule oncology treatment, with first-line non-small cell lung cancer expected to be its lead indication. BeOne describes it as a PRMT5 inhibitor.

These descriptions establish what the developers are working on. They do not establish that the treatments improve patients’ outcomes. The company statements included in the announcement express expectations about their own products and should be read as attributed developer views.

Why the pathway matters

The Innovative Licensing and Access Pathway guidance explains the practical change. A passport is the mandatory entry point to ILAP. Developers can then work with specialists from the regulator, health technology assessment bodies and the NHS on a Target Development Profile.

That profile is intended to coordinate evidence generation and identify development, evaluation and implementation issues earlier. It is a planning framework that changes as knowledge develops, rather than a replacement for clinical research or regulatory assessment.

The useful technology story is therefore broader than three product names. Complex medicines need a route from laboratory concepts through clinical evidence to workable services. Earlier coordination could reduce avoidable duplication between organisations, although the announcement supplies no measured time saving for these three projects.

What this means for Sussex patients and researchers

No Brighton or Sussex treatment service, recruitment site or allocation is announced in this statement. Readers should not interpret a UK-wide development designation as confirmation of local availability.

For university teams, biotechnology businesses and other developers, the opportunity is more immediate. The pathway accepts commercial and non-commercial applicants, including organisations outside the UK. The guidance requires evidence of safe use in humans and says confirmatory trials must not yet have started. Meeting eligibility alone does not guarantee selection.

Brighton Locals’ view

Our assessment: coordinated development support is a constructive step when it helps researchers collect the evidence that patients and health services actually need. The limit is equally clear: an administrative milestone cannot answer whether a medicine works well enough, is safe enough or represents sufficient value. Those tests must remain visible as the projects advance.

What you should do

Patients should use the announcement to understand the development stage, rather than as a reason to change treatment. It contains no patient application or booking process for these medicines.

Developers considering the next round should read the official application guidance, eligibility criteria and submission instructions. The MHRA gives 11 February 2027 as the closing date. Check the live guidance for operational details before submitting.

What to watch next

The meaningful next evidence will concern clinical results, safety, formal assessments and any confirmed access arrangements. We will judge progress against those milestones, rather than assuming that a passport guarantees a successful medicine.

Bottom line: these projects have gained a more coordinated development route, while the evidence needed to bring treatments to patients still lies ahead.

Image: archive view of 10 South Colonnade, London, MHRA’s currently listed address, photographed 1 March 2014 before its present role. The wub / Wikimedia Commons, CC BY-SA 4.0. This is not a photograph of the medicines or today’s announcement. Related coverage: Technology & Innovation.

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