Spevigo
Immunology· 565 cited findings· 1 source document
Company: LEO A S
What the regulatory reviews say
Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy. In GPP treatment courses, 41.3% of patients showed an excellent response, while 31.4% had a partial response, and 27.3% showed no response. Spevigo demonstrated a 54.3% rate of GPPGA pustulation subscore of 0.
Safety findings include an all-cause mortality rate of 2.5% for hospitalized GPP flare patients. Mortality rates due to GPP or associated treatment were reported as 2% and 16%. Anti-drug antibodies (ADA) developed in 46% of patients, with a median onset time of 2.3 weeks. The median time to maximum ADA titre was 11.7 weeks, and 24% of patients had a maximum ADA titre greater than 4000. The recommended dose of Spevigo is 900 mg, with an additional dose of 900 mg possible. The CHMP issued a positive opinion on 13 October 2022, leading to a Conditional Marketing Authorisation.
Key figures — cited to the source page
| Excellent response to GPP treatment courses | 41.3 | LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/, p.12 |
| GPPGA pustulation subscore of 0 | 54.3 | LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/, p.94 |
| All-cause mortality for hospitalized GPP flare patients | 2.5 | LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/, p.11 |
| Patients developed ADA | 46 | LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/, p.125 |
| Recommended dose of Spevigo | 900 | LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/, p.12 |
| CHMP positive opinion date | 13 October 2022 | LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/, p.9 |
| Marketing authorisation type | Conditional marketing authorisation | LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/, p.13 |
| Indication wording | Treatment of flares in adult patients with generalised pustular psoriasis as monotherapy | LEO A S — Spevigo EMA EPAR public assessment report (EMEA/H/, p.13 |
Source documents
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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.