Reagila(cariprazine)
Psychiatry· 910 cited findings· 2 source documents
Company: Gedeon Richter Plc.
What the regulatory reviews say
Reagila (cariprazine) is indicated for the treatment of schizophrenia in adult patients. The marketing authorization application was submitted on 2 March 2016, with a positive opinion from the CHMP on 18 May 2017. A new pharmaceutical form, orodispersible tablets, was introduced with a marketing authorization submission date of 22 June 2023, also for the treatment of schizophrenia in adult patients.
In efficacy studies, cariprazine 3 mg showed a change from baseline in PANSS-T score at week 6 of -17.6 compared to -11.6 for placebo (LS mean difference -6.0). For cariprazine 6 mg, the change was -20.0 compared to -11.6 for placebo (LS mean difference -8.4). Cariprazine also demonstrated a statistically significant difference in favour of cariprazine over risperidone (P=0.002) for PANSS factor score for negative symptoms change from baseline. The relapse rate for cariprazine was 24.8% compared to 47.5% for placebo.
Safety findings include cariprazine's unbound fraction of 0.04, and a half-life of 1 to 3 days. Its concentration in CSF vs plasma is 5%-10%. The proposed daily dose range is 1.5-6 mg, with an initial dose of 1.5 mg and a maximum daily dose of 6 mg.
Key figures — cited to the source page
| Change from baseline in PANSS-T score at week 6 (cariprazine 3 mg vs placebo) | -17.6 vs -11.6 (LS mean difference -6.0) | Gedeon Richter Plc. — Reagila EMA EPAR public assessment rep, p.52 |
| Change from baseline in PANSS-T score at week 6 (cariprazine 6 mg vs placebo) | -20.0 vs -11.6 (LS mean difference -8.4) | Gedeon Richter Plc. — Reagila EMA EPAR public assessment rep, p.52 |
| PANSS responders (>=30% improvement) for cariprazine 6.0 mg vs placebo | 31.8% vs 19.5% | Gedeon Richter Plc. — Reagila EMA EPAR public assessment rep, p.53 |
| Relapse rate for cariprazine vs placebo | 24.8% vs 47.5% | Gedeon Richter Plc. — Reagila EMA EPAR public assessment rep, p.77 |
| Cariprazine half-life | 1 and 3 days | Gedeon Richter Plc. — Reagila EMA EPAR public assessment rep, p.38 |
| Marketing authorization application submission date | 2 March 2016 | Gedeon Richter Plc. — Reagila EMA EPAR public assessment rep, p.8 |
| CHMP positive opinion date | 18 May 2017 | Gedeon Richter Plc. — Reagila EMA EPAR public assessment rep, p.9 |
| Proposed daily dose range | 1.5-6 mg | Gedeon Richter Plc. — Reagila EMA EPAR public assessment rep, p.11 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.