Angelini Pharma — Latuda EMA EPAR public assessment report (EMEA/H/C/002713, 2014)
Angelini Pharma · 2014 · EMA EPAR public assessment report
Report summary
The EMA's 2014 assessment of Latuda (lurasidone) for schizophrenia, submitted by Takeda Pharma A/S, covered its quality, non-clinical pharmacology, and clinical efficacy/safety. Preclinical studies showed lurasidone's affinity for dopamine/serotonin receptors, antidepressant-like effects, and identified dose-dependent prolactin increases and QT prolongation. Clinical trials demonstrated short-term efficacy across various doses, superiority over placebo in improving PANSS/CGI-S scores, and non-inferiority to quetiapine XR in long-term relapse prevention. Common adverse events included akathisia, nausea, and somnolence, with a generally favorable metabolic profile. The CHMP recommended marketing authorization for adult schizophrenia, noting a safety profile comparable to other atypical antipsychotics.
Key findings — cited to the page
| Positive opinion for granting Marketing Authorisation | 20 - 23 January 2014 | Latuda · European Union · p.7 |
| Lurasidone binding affinity for dopamine D2-receptors | 0.994 nM | · p.8 |
| Scientific Advice from CHMP | 19 May 2011 | · p.5 |
| Marketing Authorisation in Canada | 18 June 2012 | Latuda · Canada · p.6 |
| EMA Decision P/0145/2012 on agreement of paediatric investigation plan (PIP) | P/0145/2012 | Latuda · European Union · p.5 |
| Scientific Advice from CHMP | 26 January 2006 | · p.5 |
| Indication applied for | treatment of schizophrenia | Latuda · p.5 |
| Scientific Advice from CHMP | 21 September 2009 | · p.5 |
| Marketing Authorisation in USA | 28 October 2010 | Latuda · USA · p.6 |
| Marketing Authorisation Application submission date | 27 September 2012 | Latuda · European Union · p.5 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 15 March 2012 | Latuda · European Union · p.5 |
| Lurasidone binding affinity for serotonergic 5HT2A-receptors | 0.47 nM | · p.8 |
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 →