ROVI.MCROVI.MC

ROVI.MC's therapeutic focus is psychiatry. The company has developed Okedi for the treatment of schizophrenia in adults. Okedi's proposed dosage is 75 mg or 100 mg, and it has a duration of effect of 1 month (28 days). The CHMP issued a favourable recommendation for Okedi, specifically for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone. The marketing authorization application for Okedi was submitted in Europe on 27 December 2019, following an eligibility to centralised procedure agreed on 25 July 2019. The CHMP gave a positive opinion on 16 December 2021.

Clinical development for Okedi included 3 Phase 1 studies, 2 comparative bioavailability studies, 1 Phase 2 study, and 1 Phase 3 study (PRISMA-3). In the BORIS-2 study, 77 subjects were included, with 55 completing the study. The ROV-RISP-2020-02 study enrolled 25 subjects, and 18 completed it. PRISMA-1 included 36 subjects with schizophrenia or schizoaffective disorder. In PRISMA-3, the PANSS response rate (responders) was 31%, and TEAEs and related TEAEs were observed in 53% of participants. Another reported PANSS response rate (responders) in PRISMA-3 was 8.3%.