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CERDELGA (eliglustat), metabolism medicinal product
RARE DISEASE - New medicinal product
Opinions on drugs -
Posted on
Jan 18 2016
Reason for request
Inclusion
No clinical benefit demonstrated in the long-term treatment of adults with type 1 Gaucher's disease when compared with CEREZYME and VPRIV
- CERDELGA, administered orally, has Marketing Authorisation in the long-term treatment of adult patients with type 1 Gaucher's disease (GD1) who are poor metabolisers (PMs), intermediate metabolisers (IMs) or rapid metabolisers (RMs) of cytochrome 2D6 (CYP2D6).
- Its efficacy is non-inferior to that of CEREZYME for a short period of 1 year in patients stabilised on enzyme therapy.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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