Gedeon Richter Plc. — Reagila EMA EPAR variation assessment report (EMEA/H/C/002770, 2017)
Gedeon Richter Plc. · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
Gedeon Richter Plc. sought to extend the marketing authorization for Reagila (cariprazine) by introducing an orodispersible tablet formulation for adult schizophrenia patients, aiming to improve compliance, especially for those with swallowing difficulties. The application included an updated Risk Management Plan and addressed legal and pediatric requirements. Bioequivalence studies were central to the assessment, demonstrating that the new formulation is bioequivalent to the existing hard capsules for the 1.5 mg strength when taken without water. Although one study showed a slightly lower Cmax when dispersed in water, this was considered clinically insignificant due to cariprazine's pharmacokinetic profile. The report concluded that the new formulation maintains a positive benefit-risk balance for schizophrenia treatment.
Key findings — cited to the page
| Number of subjects randomized | 64 | EU-KIFO-CAR-02-2020 · p.18 |
| Number of subjects who received investigational product at least once | 62 | EU-KIFO-CAR-02-2020 · p.18 |
| Total TEAEs reported | 98 | EU-KIFO-CAR-01-2020 · p.18 |
| TEAEs after Test treatment | 54 | EU-KIFO-CAR-01-2020 · p.18 |
| Marketing authorization submission date | 22 June 2023 | Reagila · p.5 |
| New pharmaceutical form introduced | orodispersible tablets | Reagila · p.5 |
| Indication for new pharmaceutical form | treatment of schizophrenia in adult patients | Reagila · p.5 |
| EMA Decision on Paediatric Investigation Plan (PIP) | P/0162/2023 | · p.5 |
| Procedure start date | 13 July 2023 | · p.6 |
| CHMP positive opinion date | 30 May 2024 | Reagila · p.6 |
| Lifetime morbidity risk of schizophrenia | about 1 percent | worldwide · p.7 |
| Number of subjects randomized | 54 | EU-KIFO-CAR-01-2020 · p.18 |
Source: Gedeon Richter Plc. ↗ · 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 Psychiatry library →