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MHRA awards ILAP Innovation Passports to lung cancer, Huntington's and Alzheimer's candidates

🇬🇧 MHRA · Mon 09 Nov 2026

Three investigational medicines gain entry to the UK's Innovative Licensing and Access Pathway, with applications for the next round open until 11 February 2027.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Innovation Passports to three investigational medicines targeting Huntington's disease, non-small cell lung cancer (NSCLC) and early Alzheimer's disease. The passport gives developers access to coordinated support through the Innovative Licensing and Access Pathway (ILAP) during development.

The recipients were chosen by the ILAP Selection Panel. They are a chemical siRNA for Huntington's disease, a small-molecule oncology therapy with first-line NSCLC expected as the lead indication, and an antisense oligonucleotide for early Alzheimer's disease. Companies named the products as Alnylam's brezosiran, BeOne's BGB-58067 (a PRMT5 inhibitor) and Biogen's diranersen respectively. BeOne said BGB-58067 is aimed at patients with MTAP-deficient tumours and is its second medicine to enter ILAP in recent months.

The MHRA describes ILAP as an end-to-end pathway in which developers can work with the regulator, the national health system and health technology assessment bodies from early clinical development. It is delivered by the MHRA, NHS England, NICE, the Scottish Medicines Consortium, the All Wales Therapeutics and Toxicology Centre and the Department of Health Northern Ireland. NICE, the SMC and AWTTC all welcomed the awards, with NICE highlighting early engagement on evidence generation.

The agency stressed that the products remain in development and that any future availability will depend on evidence of safety, effectiveness and value. A passport is therefore an entry point to the pathway, not a marketing authorisation. The next round of applications opens on 9 November and closes on 11 February 2027; entry is open to commercial and non-commercial developers worldwide.

What it means for your team

  • Developers of products for unmet needs can apply for the next Innovation Passport round between 9 November 2026 and 11 February 2027.
  • Regulatory teams should note that ILAP brings the MHRA and the UK HTA bodies together early, which may shape evidence plans for both licensing and reimbursement.
  • Market-access teams should treat the awards as a sign of early engagement only; the MHRA says nothing on safety or efficacy is implied.
  • Teams working in neurodegeneration and oncology can track brezosiran, BGB-58067 and diranersen as they progress through the pathway.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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