Laboratorios Farmaceuticos Rovi, S.A. — Okedi EMA EPAR public assessment report (EMEA/H/C/005406, 2022)
Laboratorios Farmaceuticos Rovi, S.A. · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Okedi (risperidone), a hybrid medicinal product for schizophrenia, led to a positive CHMP opinion for marketing authorization. Okedi is a prolonged-release risperidone microparticle formulation for intramuscular injection, referencing oral Risperdal. Its development included extensive pharmaceutical, non-clinical, and clinical studies. The clinical program, including the pivotal PRISMA-3 study, demonstrated significant efficacy in improving PANSS and CGI-S scores in acute schizophrenia exacerbation for both 75 mg and 100 mg doses, with a safety profile consistent with established risperidone formulations. PK/PD modeling confirmed dose proportionality and characterized the relationship between drug concentration and efficacy/adverse events. While trials did not observe rare severe adverse reactions like NMS or tardive dyskinesia, the CHMP emphasized establishing oral risperidone tolerability before initiating Okedi, particularly in elderly or risperidone-naïve patients. Overall, a positive benefit-risk balance was concluded for Okedi in adults with established oral risperidone tolerability and effectiveness.
Key findings — cited to the page
| Indication | treatment of schizophrenia in adult patients with acute exacerbation where psychotic symptoms are moderate to severe | Okedi · p.5 |
| Reference product name | Risperdal | Okedi · p.5 |
| Indication | treatment of schizophrenia in adults | Okedi · p.5 |
| TEAEs and related TEAEs | 53 % | PRISMA-3 · p.79 |
| PANSS response rate (responders) | 8.3 % | PRISMA-3 · p.73 |
| Indication | treatment of schizophrenia in adult patients previously stabilised with antipsychotics | Okedi · p.5 |
| PANSS response rate (responders) | 31 % | PRISMA-3 · p.73 |
| Eligibility to centralised procedure agreed date | 25 July 2019 | Okedi · Europe · p.5 |
| CHMP recommendation for Okedi | favourable | Okedi · p.99 |
| Indication for Okedi | Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone | Okedi · p.99 |
| Marketing authorization application submission date | 27 December 2019 | Okedi · Europe · p.5 |
| Reference product strength | 4 mg | Okedi · p.5 |
Source: Laboratorios Farmaceuticos Rovi, S.A. ↗ · 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 →