Amylyx Pharmaceuticals provides update on Accès Compassionnel for AMX0035 in France

Amylyx Pharmaceuticals

5 October 2023 - L’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), the national authority for authorising medicinal products in France, has granted “accès compassionnel” (compassionate access) to AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) for eligible people living with amyotrophic lateral sclerosis following a collaborative process involving medical experts, ARSLA and other ALS advocates, ANSM, and Amylyx Pharmaceuticals.

Separately, the formal re-examination procedure of the Marketing Authorisation Application of AMX0035 for the treatment of adults with amyotrophic lateral sclerosis in the European Union remains underway.

Read Amylyx Pharmaceuticals press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , Market access , France