Myrtelle’s rAAV-Olig001-ASPA Gene Therapy Candidate for Canavan Disease Receives Innovative Licensing and Access Pathway Designation from the UK Medicines and Healthcare Products Regulatory Agency
Myrtelle Inc. , (“Myrtelle” or the “Company”), a clinical stage gene therapy company focused on developing transformative treatments for neurodegenerative diseases, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA), the healthcare regulatory body of the United Kingdom (UK), granted Innovative Licensing and Access Pathway (ILAP) designation to the Company's lead gene therapy product candidate, rAAV-Olig001-ASPA for the treatment of Canavan disease.
- Myrtelle Inc. , (“Myrtelle” or the “Company”), a clinical stage gene therapy company focused on developing transformative treatments for neurodegenerative diseases, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA), the healthcare regulatory body of the United Kingdom (UK), granted Innovative Licensing and Access Pathway (ILAP) designation to the Company's lead gene therapy product candidate, rAAV-Olig001-ASPA for the treatment of Canavan disease.
- ILAP provides expedited access to a range of UK development services and tools for life-threatening or seriously debilitating conditions for which there is a significant patient need.
- These services include the potential for frequent MHRA interactions, accelerated Marketing Authorization Application (MAA) assessment, innovative and flexible licensing routes, engagement on market access activities, and a continuous benefit-risk assessment integrating real world evidence.
- Myrtelle entered into an exclusive worldwide licensing agreement with Pfizer Inc. in 2021 to develop and commercialize this novel gene therapy for the treatment of CD.