Johnson & Johnson — Trevicta (previously Paliperidone Janssen) EMA EPAR variation assessment report (EMEA/H/C/004066, 2014)
Johnson & Johnson · 2014 · EMA EPAR variation assessment report · company profile →
Report summary
This EMA EPAR variation assessment report details the regulatory review of Trevicta (paliperidone palmitate 3-month injection, PP3M) for schizophrenia. Janssen-Cilag sought approval for new strengths and an updated indication for maintenance treatment. Non-clinical and clinical studies demonstrated PP3M's slow release pharmacokinetics and efficacy. Key findings include its non-inferiority to the 1-month formulation (PP1M) in relapse prevention and superiority over placebo in delaying relapse, with a 74% reduced relapse risk. The safety profile of PP3M was consistent with PP1M and other paliperidone formulations, showing no new safety concerns regarding cardiovascular, endocrine, metabolic, or injection site reactions. While potential risks like gastrointestinal obstruction and decreased bone mineral density were noted, the overall benefit-risk balance for PP3M was deemed positive.
Key findings — cited to the page
| increase in total cholesterol | 1.4% | PSY-3012 · p.35 |
| discontinuation due to adverse events | 2.5 % | PP1M (PSY-3011) · p.47 |
| akathisia incidence | 4 % | PP3M · p.47 |
| Procedure Number | EMEA/H/C/004066/X/0007/G | Trevicta · p.1 |
| Application submission date | 28 July 2015 | Trevicta · European Union · p.5 |
| New strengths of 3-month paliperidone injection | 175, 263, 350, 525 mg | Trevicta · European Union · p.5 |
| Paliperidone Janssen Marketing Authorisation date | 05/12/2014 | Paliperidone Janssen · EU · p.5 |
| CHMP positive opinion date | 1 April 2016 | Trevicta · p.6 |
| Schizophrenia worldwide prevalence | 0.45 % | Global · p.6 |
| Schizophrenia annual incidence | 15 per 100,000 | · p.6 |
| Paliperidone palmitate 3-month formulation concentration | 312 mg/mL | PP3M · p.12 |
| shift from normal to low HDL cholesterol (≥40 to <40 mg/dL) | 15.8% | PSY-3011 · p.35 |
Source: Johnson & Johnson ↗ · 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 →