Nordimet
Immunology· 123 cited findings· 1 source document
Company: Nordic B V
What the regulatory reviews say
Nordimet is indicated for severe recalcitrant disabling psoriasis and severe psoriatic arthritis in adult patients. A Type II variation application was submitted on 4 November 2022 to expand the indication to include moderate to severe recalcitrant disabling psoriasis. The CHMP Opinion date was 14 September 2023.
Efficacy findings include a PASI 75 response rate of 41% and 78% in different studies, with a PASI75 reduction from baseline of 45.2% compared to 4.4% for placebo. Physician's Global Assessment 0 or 1 was achieved by 80.5% of patients, compared to 34.4% for placebo. Methotrexate, the active ingredient, has a mean oral bioavailability of 70% at low doses, with plasma peak concentration attained in 1-2 hours.
Safety data indicates serious adverse events in 9.1% of patients, serious infections in 2.6%, and cancers in 1.9%. Overall, adverse events were reported in 65% of patients, and side-effects in 73%.
Key figures — cited to the source page
| PASI 75 response rate | 41 | Nordic B V — Nordimet EMA EPAR variation assessment report (, p.20 |
| PASI 75 response rate (placebo) | 10 | Nordic B V — Nordimet EMA EPAR variation assessment report (, p.20 |
| PASI75 reduction from baseline | 45.2 | Nordic B V — Nordimet EMA EPAR variation assessment report (, p.21 |
| PASI75 reduction from baseline (placebo) | 4.4 | Nordic B V — Nordimet EMA EPAR variation assessment report (, p.21 |
| Physician's Global Assessment 0 or 1 (%) | 80.5 | Nordic B V — Nordimet EMA EPAR variation assessment report (, p.23 |
| Physician's Global Assessment 0 or 1 (%) (placebo) | 34.4 | Nordic B V — Nordimet EMA EPAR variation assessment report (, p.23 |
| Serious adverse events (%) | 9.1 | Nordic B V — Nordimet EMA EPAR variation assessment report (, p.23 |
| Adverse Events reported (%) | 65 | Nordic B V — Nordimet EMA EPAR variation assessment report (, p.23 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.