Lysogene announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has awarded LYS-GM101 investigational gene therapy an ‘Innovation Passport’ for the treatment of GM1 gangliosidosis under the United Kingdom’s (UK) Innovative Licensing and Access Pathway (ILAP). The decision was made by the ILAP Steering Group, which is comprised of representatives from MHRA, National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC), All Wales Therapeutics and Toxicology Centre (AWTTC) and representatives from the ILAP Patient and Public Reference Group. The Innovation Passport is the entry point to ILAP, designed to accelerate the development and access to promising medicines in the UK, thereby facilitating and improving patient access to new medicines. ILAP was introduced by MHRA in January 2021 and is aimed at facilitating development of and patients’ access to promising innovative medicinal products. The regulatory pathway involves close engagement with other stakeholders, including patient representatives. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment.