Okedi
Psychiatry· 271 cited findings· 1 source document
Company: Laboratorios Farmaceuticos Rovi, S.A.
What the regulatory reviews say
Okedi is indicated for the treatment of schizophrenia in adults. Specifically, it is for adult patients for whom tolerability and effectiveness have been established with oral risperidone. The CHMP issued a favourable recommendation for Okedi.
In efficacy trials, the PANSS response rate (≥30% decrease) at Day 85 was 38.0%, with a difference versus placebo of 29.7%. At Endpoint, the PANSS response rate (≥30% decrease) was 41.9%, with a difference versus placebo of 32.8%. The PANSS total score change from baseline to Day 85 showed a least squares mean difference versus placebo of -13.6.
Regarding safety, 53% of patients experienced Treatment-Emergent Adverse Events (TEAEs), with 67% of these being mild. Patient exposure included 579 patients in total, with 185 patients receiving at least 6 doses and 118 patients receiving at least 12 doses. Early treatment discontinuation in the Open-Label Extension (OLE) phase ranged from 22.6% to 26.9%.
Key figures — cited to the source page
| PANSS response rate (≥30% decrease) at Day 85 | 38.0% | Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR publi, p.65 |
| PANSS response rate difference vs placebo at Day 85 | 29.7% | Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR publi, p.65 |
| PANSS total score change from baseline to Day 85 (LS Means Difference vs Placebo) | -13.6 | Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR publi, p.62 |
| TEAEs and related TEAEs | 53 | Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR publi, p.79 |
| Patient exposure | 579 | Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR publi, p.77 |
| Early treatment discontinuation (OLE phase) | 24.6 | Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR publi, p.70 |
| CHMP recommendation for Okedi | favourable | Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR publi, p.99 |
| Indication for Okedi | Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone | Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR publi, p.99 |
Source documents
Explore the full evidence
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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.