MHRA’s ILAP Passports Go to Liver Cancer, Dementia Drugs

Two investigational medicines — one for a form of dementia, one for the most common primary liver cancer — cleared the entry gate to the UK's Innovative Licensing and Access Pathway on August 4, the same day MHRA opened the program's next application round. The Innovation Passport is not a marketing authorization and guarantees nothing about eventual approval. What it buys a sponsor is something regulators outside the UK still don't offer as a package: coordinated, simultaneous early guidance from the medicines regulator, the national health system, and the bodies that decide whether a drug is worth paying for.

What an Innovation Passport actually is

ILAP, relaunched with a tougher bar in early 2025, is built around a sequence: a sponsor applies for an Innovation Passport, which is awarded by joint consensus of MHRA, NHS England, and HTA representatives to products judged to address an unmet clinical need with the potential for significant patient benefit. Passport in hand, the sponsor and the partner bodies build a Target Development Profile — a tailored roadmap covering the evidence, regulatory, and access questions specific to that product, rather than the one-size-fits-all sequence of a standard development program. MHRA has said the raised entry bar means comparatively few candidates have cleared it since the relaunch, which is part of why any new cohort of passports draws notice from sponsors weighing whether to apply.

Two products, two different unmet needs

CervoMed's neflamapimod targets dementia with Lewy bodies, a neurodegenerative condition with no therapy specifically approved for it and a diagnostic and treatment landscape that lags well behind Alzheimer's disease. BeOne Medicines' BGB-B2033 is a bispecific antibody aimed at hepatocellular carcinoma, where systemic options for patients who progress past first-line therapy remain limited. Neither passport says anything yet about clinical outcomes; what it signals is that MHRA, NHS England, and the HTA bodies judged both programs credible enough, and the underlying need serious enough, to commit to coordinated early engagement rather than leaving each sponsor to navigate the regulator, the health system, and the reimbursement bodies separately and sequentially.

• An Innovation Passport is a development-track designation, not an approval — it does not shorten a statutory review clock the way an accelerated-assessment designation can.
• The Target Development Profile that follows a passport is bespoke to each product, built jointly with MHRA, NHS England, and the relevant HTA body.
• ILAP's quarterly application cycle means the next chance to apply after this round closes November 4, 2026 will fall roughly three months later.
• Sponsors outside the UK can apply; ILAP does not require an existing UK regulatory or commercial presence to seek a passport.

Why a UK-only pathway matters to a global regulatory calendar

ILAP's pitch is coordination that most jurisdictions still handle in sequence: a company can spend years satisfying a regulator's evidentiary bar only to discover, at the reimbursement stage, that the health-technology assessment body wanted a different trial design or endpoint. Aligning those conversations from early development doesn't guarantee a faster or more favorable outcome, but it narrows the odds of a costly late-stage mismatch. For companies already running FDA and EMA development tracks in parallel, an ILAP passport is a bet that UK-specific early alignment is worth the extra process — a calculus similar to what sponsors weigh when FDA convenes an advisory committee mid-review: another forum, another set of stakeholders, and, if it goes well, one fewer surprise later in the process.