Orphelia S A S — Kigabeq EMA EPAR public assessment report (EMEA/H/C/004534, 2018)
Orphelia S A S · 2018 · EMA EPAR public assessment report
Report summary
ORPHELIA Pharma SAS sought marketing authorization for Kigabeq (vigabatrin), a new age-appropriate formulation (scored soluble tablets) for infants and children (1 month to <7 years) with infantile spasms or resistant partial epilepsy. This formulation aims to improve dose adjustment and administration compared to existing Sabril granules. Pharmaceutical development confirmed rapid dissolution and stability. Non-clinical data aligned with vigabatrin's known safety profile, including visual field constriction. Bioequivalence was demonstrated for the 500 mg strength against Sabril, with a biowaiver for 100 mg. Clinical studies confirmed compatibility with nasogastric tubes and acceptable palatability and ease of use. The safety profile, consistent with vigabatrin, includes visual field defects and suicidality. The CHMP concluded a positive benefit/risk ratio, recommending marketing authorization for Kigabeq.
Key findings — cited to the page
| Disintegration time of soluble tablets (clinical practice conditions) | less than 30 seconds | Kigabeq · p.14 |
| Dissolution of active substance | more than 85 % | Kigabeq · p.14 |
| Serious Adverse Events | No | · p.29 |
| Disintegration time of soluble tablets (Ph. Eur. conditions) | less than 1 minute | Kigabeq · p.14 |
| Marketing Authorisation Application submission date | 29 May 2017 | Kigabeq · p.7 |
| CHMP positive opinion date | 26 July 2018 | KIGABEQ · p.9 |
| EMA/CHMP eligibility agreement date | 23 June 2016 | Kigabeq · p.7 |
| Adverse Events after Test treatment | 5 | · p.29 |
| Reference product marketing authorisation date | 22 March 1993 | SABRIL 500 mg Granules for oral solution in sachet · France · p.7 |
| Geometric Mean Ratio Test/Ref for Cmax | 103.06 % | · p.29 |
| Procedure start date | 17 August 2017 | · p.8 |
| Dissolution time of active substance | 3 minutes | Kigabeq · p.14 |
Source: Orphelia S A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →