The Beneluxa iniative identified thirteen impactful medicines suitable for joint HTA submission

Starting from more than 200 medicines in the pipeline (status January 2024) mentioned in The High Impact Reports of the International Horizon Scan Initiative, a selection of impactful medicines was made. Criteria such as new chemical entity and potential game changer in clinical prescription were applied. The members of the Beneluxa Initiative established the following list of medicines, in alphabetic order, for which the Beneluxa Initiative would be interested to start a joint and full assessment:

 

Active principle

Condition

Pharmaceutical company

1.

blarcamesine

Rett syndrome

Anavex Life Sciences

2.

delandistrogene moxeparvovec

Duchenne muscular dystrophy

Hoffmann-La Roche

3.

encaleret

hypoparathyroidism

Bridge Bio Pharma

4.

ganaxolone

CDKL5 deficiency disorder

Marinus Pharmaceuticals

5.

givinostat

Duchenne muscular dystrophy

Italfarmaco

6.

hypericin

Cutaneous T-cell lymphoma

Minoryx Therapeutics

7.

leniolisib

Activated PI3 kinase delta syndrome

Pharming Group

8.

leriglitazone

Adrenoleukodystrophy

Minoryx Therapeutics

9.

lonafarnib

Hepatitis D

Eiger Bio Pharmaceutica

10.

marnetegragene autotemcel

Leukocyte adhesion deficiency type I

Rocket Pharmaceuticals

11.

N-acetyl-L-leucine

Niemann-Pick disease

IntraBio

12.

sparsentan

IgA nephropathy

CSL Vifor

13.

trofinetide

Rett syndrome

Acadia Pharmaceuticals

 

If pharmaceutical companies are interested in the possibility of a joint submission for a joint HTA procedure across jurisdictions, the Beneluxa Initiative is willing to organize an exploratory meeting.

It is to be stressed that, beyond this list, Beneluxa remains open for other medicines for which companies seek to submit jointly in more than one member state.


 Last update: 20 January 2025