Nordic B V — Nordimet EMA EPAR variation assessment report (EMEA/H/C/003983, 2016)
Nordic B V · 2016 · EMA EPAR variation assessment report
Report summary
Nordic Group B.V. applied for a Type II variation to extend Nordimet (methotrexate) indication to moderate to severe recalcitrant disabling psoriasis. This application, based on published literature, found no significant environmental impact. Methotrexate demonstrates efficacy in treating psoriasis, achieving PASI75 responses, often comparable to other treatments. While effective, it carries known risks, including liver enzyme elevations, gastrointestinal issues, and other toxicities (pulmonary, renal, haematological). Folate supplementation helps mitigate adverse effects. The report concludes that the benefit-risk balance supports this indication extension, with updates to the EPAR and a comprehensive reference list provided.
Key findings — cited to the page
| Hepatotoxicity (grade III or IV) | 3 -25 % | · p.33 |
| Type II variation application submission date | 4 November 2022 | Nordimet · p.4 |
| Proposed new indication | moderate to severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients | Nordimet · p.6 |
| CHMP Opinion date | 14 September 2023 | · p.5 |
| Currently approved indication | severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients | Nordimet · p.6 |
| Variation type | C.I.6.a - Change(s) to therapeutic indication(s) - Addition of a new therapeutic indication or modification of an approved one | Nordimet · p.4 |
| PASI75 reduction from baseline (placebo) | 4.4 % | · p.21 |
| PASI75 estimate (pooled) | 45.2 % | · p.21 |
| PASI 75 response rate | 41 % | METOP · Germany, France, Netherlands, United Kingdom · p.20 |
| PASI 75 response rate | 10 % | METOP · Germany, France, Netherlands, United Kingdom · p.20 |
| Proposed new indication | moderate to severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis | · p.14 |
| PASI75 reduction from baseline | 45.2 % | · p.21 |
Source: Nordic B V ↗ · 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 Immunology library →