Bial Portela C S A — Ongentys EMA EPAR public assessment report (EMEA/H/C/002790, 2016)
Bial Portela C S A · 2016 · EMA EPAR public assessment report
Report summary
The EMA's 2016 assessment of Ongentys (opicapone) for Parkinson's disease with motor fluctuations concluded with a recommendation for marketing authorization. Quality, non-clinical pharmacology, pharmacokinetics, and toxicology were deemed acceptable, with no significant genotoxicity or carcinogenicity concerns. Clinical development, including 27 Phase 1, 2 Phase 2, and 2 Phase 3 studies (1651 subjects), demonstrated opicapone's efficacy. Specifically, 50 mg opicapone significantly reduced "OFF-time" and increased "ON-time" compared to placebo, and was non-inferior to entacapone. The most common adverse event was dyskinesia, with a higher incidence in opicapone groups. Other safety concerns included CPK elevation. Overall, opicapone 50 mg showed a favorable benefit-risk profile.
Key findings — cited to the page
| Daphnia sp. Reproduction Test (NOEC) | 8.8 mg/L | Ongentys · p.23 |
| Scientific Advice from CHMP date 1 | 19 January 2012 | · p.5 |
| Marketing Authorisation application submission date | 25 November 2014 | Ongentys · EU · p.5 |
| Procedure start date | 24 December 2014 | · p.6 |
| Positive opinion for Marketing Authorisation date | 28 April 2015 | Ongentys · p.7 |
| Prevalence of Parkinson's disease for subjects aged 65 years or older | 1.6% | · p.8 |
| Scientific Advice from CHMP date 2 | 18 October 2012 | · p.5 |
| Eligibility to centralised procedure agreed date | 19 July 2012 | Ongentys · EU · p.5 |
| Prevalence of Parkinson's disease in 65 to 69 years age group | 0.6% | · p.8 |
| Prevalence of Parkinson's disease in 85 to 89 years age group | 3.5% | · p.8 |
| Mean age of onset of Parkinson's disease | 60 years | · p.8 |
| Orphan market exclusivity expiry date for Duodopa | 18 November 2015 | Duodopa · p.5 |
Source: Bial Portela C S A ↗ · 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 Neurology library →