Amylyx Pharmaceuticals Provides Update on Accès Compassionnel for AMX0035 in France
Retrieved on:
Thursday, October 5, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, European, ALS, European Directive on Traditional Herbal Medicinal Products, CHMP, Committee for Medicinal Products for Human Use, ANSM, European Medicines Agency, EMA, Marketing, Committee, Nursing, Vaccine, Amylyx Pharmaceuticals, AMX0035, EU
AMX0035 is known as RELYVRIO® in the United States and ALBRIOZA™ in Canada.
Key Points:
- AMX0035 is known as RELYVRIO® in the United States and ALBRIOZA™ in Canada.
- For more information, including eligibility criteria, please visit here .
- Separately, the formal re-examination procedure of the Marketing Authorisation Application of AMX0035 for the treatment of adults with ALS in the European Union (EU) remains underway.
- Amylyx continues to engage with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to prioritize broad and sustainable access to AMX0035 through the central EU review and approval process.