Angelini Pharma — Latuda EMA EPAR variation assessment report (EMEA/H/C/002713, 2014)
Angelini Pharma · 2014 · EMA EPAR variation assessment report
Report summary
This report details the Type II variation application for Latuda (lurasidone) to extend its indication for schizophrenia treatment to adolescents aged 13 and over. Non-clinical studies in juvenile rats revealed dose-related effects on growth, development, and reproductive parameters. Clinical trials demonstrated significant short-term efficacy in adolescents, with lurasidone (40mg/day and 80mg/day) improving PANSS and CGI-S scores compared to placebo. Long-term studies showed maintained efficacy and a safety profile generally consistent with adults, though common adverse events included nausea, vomiting, somnolence, akathisia, and elevated prolactin. Safety concerns also encompassed extrapyramidal symptoms, metabolic changes, and suicidality. The report concludes with identified risks and the pharmacovigilance plan.
Key findings — cited to the page
| Lurasidone effect on female rat reproduction (oral dose) | 0.1 mg/kg/day | · p.8 |
| Lurasidone effect on male rat reproduction (oral dose) | 150 mg/kg/day | · p.8 |
| menstrual related AEs: dysmenorrhea, galactorrhea, and menstruation irregular | 3 subjects each | · p.67 |
| menstrual related AEs: dysmenorrhea, galactorrhea, and menstruation irregular | 1.1 % | · p.67 |
| Scientific advice from EMA date | 23 of February 2017 | · p.5 |
| Lurasidone approval date for adult schizophrenia in EU | 21 March 2014 | EU · p.6 |
| Type II variation application date | 19 November 2019 | · p.5 |
| Lurasidone binding affinity to serotonergic 5-HT7 receptors | 0.495 nM | · p.6 |
| EMA Decision on paediatric investigation plan (PIP) | P/0359/2019 | · p.5 |
| Lurasidone binding affinity to α2c-adrenergic receptors | 10.8 nM | · p.6 |
| Lurasidone binding affinity to α2a-adrenergic receptors | 40.7 nM | · p.6 |
| Lurasidone binding affinity to serotonergic 5-HT2A receptors | 0.47 nM | · p.6 |
Source: Angelini Pharma ↗ · 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 →