NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Innovative Licensing and Access Pathway

The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the approval process for new medicines and repurposed medicines for life threatening or seriously debilitating conditions, so that patients can access them faster. This is achieved in partnership with other health bodies, supporting the manufacturer through the licensing process, while still ensuring these are safe and fit for purpose.

Our partners in ILAP are All Wales Therapeutic and Toxicology Centre (AWTCC), the National Institute for Clinical Excellence (NICE), and the Scottish Medicines Consortium (SMC).

Medicines on the ILAP pathway, which fulfil the criteria, are awarded an Innovation Passport designation initially. They can then progress to a Target Development Profile, if they are intending to progress to market, which sets out a regulatory roadmap for delivery to patients.

To date we have received 178 applications from a range of pharmaceutical companies and awarded 129 Innovation Passports, including one for a ground-breaking immunotherapy for the treatment of Alzheimer’s disease. 40 products have progressed to a TDP with 26 TDP regulatory roadmaps issued.

Project Orbis

Project Orbis is a collaborative programme, led by the US Food and Drug Administration (FDA), which reviews and approves promising cancer drugs, enabling patients to access these treatments more rapidly. MHRA is a partner in Project Orbis alongside regulatory authorities from Australia, Canada, Singapore, Switzerland, and Brazil.

In 2022/23, through Project Orbis, the MHRA approved four new medicines and new uses for three existing cancer medicines, including nivolumab (Opdivo) for use in non-small cell lung cancer in adults, darolutamide (Nubeqa) for the treatment of certain prostate cancers and durvalumab (Imfinzi) for the treatment of metastatic biliary tract cancer.

Medicines intended for use in Great Britain must meet the qualifying criteria for ILAP in order to be considered for Project Orbis.

📰 Our Annual Report for 2022/23 is out now.

From cutting-edge science and supporting innovation to criminal enforcement and improving patient access, read all about the MHRA’s work over the past year.

Check out our Annual Report here 👉 https://t.co/X0jxsQJFWV pic.twitter.com/OLk30JECrA

— MHRAgovuk (@MHRAgovuk) July 19, 2023