Gedeon Richter Plc. — Reagila EMA EPAR public assessment report (EMEA/H/C/002770, 2017)
Gedeon Richter Plc. · 2017 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted marketing authorization for Reagila (cariprazine) in May 2017 for treating adult schizophrenia. Cariprazine, a partial agonist at dopamine D2/D3 and serotonin 5-HT1A receptors, demonstrated efficacy in improving positive and negative symptoms, and preventing relapse in clinical trials. Non-clinical studies revealed potential reproductive toxicity, CNS, cardiovascular, and ocular effects (cataracts), and organ toxicities. Clinical safety concerns include akathisia, hypertension, CPK elevations, metabolic changes, and ocular adverse events, though hyperprolactinemia was less frequent than with other antipsychotics. The benefit-risk assessment was positive, leading to approval.
Key findings — cited to the page
| Higher rate of premature death in schizophrenia patients | 40-60 % | · p.10 |
| Proposed daily dose range | 1.5-6 mg | Reagila · p.11 |
| Schizophrenia patients remaining significantly impaired | 40-60 % | · p.10 |
| Marketing authorization application submission date | 2 March 2016 | Reagila · European Union · p.8 |
| EMA/CHMP eligibility agreement date | 21 June 2012 | Reagila · European Union · p.8 |
| Proposed indication | Treatment of schizophrenia in adult patients. Treatment of schizophrenia with predominant negative symptoms in adult patients. | Reagila · p.8 |
| CHMP positive opinion date | 18 May 2017 | Reagila · European Union · p.9 |
| Schizophrenia affected population | 21 million people | Worldwide · p.10 |
| Schizophrenia incidence rate | 0.1 and 0.4 per 1000 population | · p.10 |
| Schizophrenia patients with good outcome | 10-20 % | · p.10 |
| Schizophrenia patients with moderate symptoms | 20-30 % | · p.10 |
| Initial dose | 1.5 mg | Reagila · p.11 |
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 →