Unknown MAH — Byannli (previously Paliperidone Janssen-Cilag International) EMA EPAR variation assessment report (EMEA/H/C/005486, 2020)
Unknown MAH · 2020 · EMA EPAR variation assessment report
Report summary
This report details the EMA's assessment of BYANNLI (paliperidone palmitate), a 6-monthly long-acting injectable for schizophrenia. The application sought to add 700 mg and 1000 mg strengths and change the product name from Paliperidone Janssen-Cilag International. Non-clinical studies in minipigs assessed local tolerance and systemic effects. Clinical pharmacology focused on the pharmacokinetic profile of the 6-month formulation (PP6M) compared to existing 1-month and 3-month formulations. A pivotal Phase 3 non-inferiority study (PSY3015) demonstrated PP6M's efficacy in preventing relapse was non-inferior to the 3-month formulation (PP3M) in stable schizophrenia patients. While injection site reactions were more frequent with PP6M, its overall safety profile was similar to PP3M, with no new significant safety signals. The benefit-risk balance was considered positive, leading to a recommendation for marketing authorization extension.
Key findings — cited to the page
| Marketing authorisation extension recommendation | recommended | BYANNLI · p.81 |
| Product name change from | Paliperidone Janssen-Cilag International | BYANNLI · p.6 |
| New strengths added | 700 mg and 1000 mg | BYANNLI · p.6 |
| Strengths deleted | 25 mg, 50 mg, 75 mg, 100 mg and 150 mg/100 mg | Paliperidone Janssen-Cilag · p.6 |
| Indication | maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly or 3-monthly paliperidone palmitate injectable products | BYANNLI · p.6 |
| Number of Phase 3 studies for PP6M | 2 | PP6M · p.7 |
| Pivotal study design | multinational, randomized, double-blind, active-controlled, non-inferiority study to compare PP6M with PP3M | Study R092670PSY3015 · p.7 |
| Open-label extension study design | multinational, single-arm 24-month open-label extension | Study R092670PSY3016 · p.7 |
| Non-inferiority margin recommended | -10% | PSY3015 study · p.8 |
| Maximum PP6M injection volume | 5 mL | PP6M · p.8 |
| CHMP positive opinion date | 16 September 2021 | BYANNLI · p.9 |
| Injection site pain TEAE (PP3M active control) | 4.0 % | PSY3015 · p.80 |
Source: Unknown MAH ↗ · 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 →