Posted by Michael Wonder on 20 Feb 2023
Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA
20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102.
In the last two weeks, Azafaros has been granted the following designations:
- Two rare paediatric disease designations by the US FDA for the treatment of GM1 and GM2 gangliosidoses
- Orphan medicinal product designation by the EMA for the treatment of GM2 gangliosidosis
- An Innovation Passport by the UK MHRA for the treatment of GM1 and GM2 gangliosidoses
