EMEA-002822-PIP01-20
Key facts
Active substance |
2’-O-(2-methoxyethyl) modified antisense oligonucleotide targeting glial fibrillary acidic protein pre-mRNA (ION373)
|
Therapeutic area |
Neurology
|
Decision number |
P/0539/2021
|
PIP number |
EMEA-002822-PIP01-20
|
Pharmaceutical form(s) |
Solution for injection
|
Condition(s) / indication(s) |
Treatment of Alexander disease
|
Route(s) of administration |
Intrathecal use
|
Contact for public enquiries |
Ionis Pharmaceuticals
Email: globalregulatoryaffairs@ionisph.com |
Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|