The Beneluxa initiative identified four impactful medicines suitable for a joint submission

The members of the Beneluxa Initiative have reviewed the Dutch Horizon Scan 2023-2024 of upcoming marketing authorization of medicines. Using selection criteria such as expected therapeutic impact and excluding extensions of indications, the following list of medicines was generated for which Beneluxa would like to start a joint evaluation:
-    Fezolinetant – menopause symptoms – Astellas
-    Leriglitazone – X-linked adrenoleukodystrophy – Minoryx
-    Phenylbutyrate/tauroursodeoxycholic acid – Amyotrophic lateral sclerosis – Amylyx
-    Vamorolone – Duchenne’s disease – Santhera Pharmaceuticals

The companies involved will be invited soon by the Beneluxa Initiative to discuss the possibility of a future Beneluxa joint submission in two or more member states. Fruitful discussions are expected at informal meetings.
The Steering Committee wants to stress that the Initiative remains open for other medicines where companies are interested to submit a joint dossier.

Last update: 13 March 2023