Otsuka Holdings Co., Ltd. — Abilify Maintena EMA EPAR public assessment report (EMEA/H/C/002755, 2013)
Otsuka Holdings Co., Ltd. · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Otsuka Holdings' Abilify Maintena (aripiprazole) for maintenance treatment of adult schizophrenia led to a positive marketing authorization opinion on September 19, 2013. The prolonged-release intramuscular depot formulation's manufacturing process, stability, and non-clinical aspects were thoroughly reviewed. Non-clinical studies revealed dose-related carcinogenicity, reproductive toxicity (maternal toxicity, suppressed fetal growth), and consistent, often irreversible, injection site reactions. Pharmacokinetic analysis showed elimination half-lives of 29.9-46.5 days. A pivotal Phase III trial (31-07-247) demonstrated non-inferiority to oral aripiprazole and superior efficacy over pseudo-placebo in preventing relapse. Common adverse events included weight gain, akathisia, and injection site pain. The CHMP noted leukopenia as a risk and recommended a post-authorization safety study for extrapyramidal symptoms.
Key findings — cited to the page
| Abilify Maintena first dose concurrent oral treatment duration | 14 days | Abilify Maintena · p.9 |
| Abilify Maintena target administration volume | 2 ml | Abilify Maintena · p.11 |
| Abilify Maintena strength | 300 mg | Abilify Maintena · p.9 |
| Abilify Maintena lower maintenance dose | 300 mg | Abilify Maintena · p.9 |
| Abilify Maintena first dose concurrent oral aripiprazole range | 10 mg to 20 mg | Abilify Maintena · p.9 |
| Abilify Maintena concentration | 200 mg/ml | Abilify Maintena · p.9 |
| Indication applied for | maintenance treatment of schizophrenia in adults | Abilify Maintena · Europe · p.6 |
| CHMP positive opinion date | 19 September 2013 | Abilify Maintena · Europe · p.7 |
| Abilify Maintena strength | 400 mg | Abilify Maintena · p.9 |
| Abilify Maintena proposed starting and maintenance dose | 400 mg | Abilify Maintena · p.9 |
| Marketing Authorisation application submission date | 30 November 2012 | Abilify Maintena · Europe · p.6 |
| estimated relapse rate | 7.76% | study 31-07-247 · p.67 |
Source: Otsuka Holdings Co., Ltd. ↗ · 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 →