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This approach is part of the recent initiative of the British MHRA to accelerate the development of and access to innovative medicines in the United Kingdom.
This designation once again reflects the recognition by regulatory authorities of the potential of Lysogene’s LYS-GM101 program in the treatment of patients with GM1 gangliosidosis.
“We are very happy to have obtained the Innovation Passport” declared Marie Deneux, Director of Regulatory Affairs and Quality Assurance at Lysogene. “Ensuring that patients with GM1 gangliosidosis benefit from LYS-GM101 is one of Lysogene’s top priorities. We will now work with the MHRA and its partners to create a target development profile (TDP) specific to the LYS-GM101 product, and to facilitate patient access to gene therapy treatment. “