ARTG Entry
SPEVIGO
ARTG entry for SPEVIGO (spesolimab), ARTG 470405 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: LEO Pharma
- Active ingredient: spesolimab
- Therapeutic area: Dermatology
What it is
SPEVIGO is a spesolimab concentrated solution for infusion or solution for injection, available in three formulations: 450 mg in 7.5 mL concentrated solution for infusion vial, 150 mg in 1 mL solution for injection pre-filled syringe, and 300 mg in 2 mL solution for injection pre-filled syringe.
Approved indications
— Treatment of flares in adult patients with generalised pustular psoriasis.
Key safety warnings
SPEVIGO has been found to be well-tolerated for the treatment of generalised pustular psoriasis flares in adults.
Regulatory history
SPEVIGO received TGA approval on 5 September 2023 for the treatment of flares in adult patients with generalised pustular psoriasis, with the product entered onto the ARTG on 24 November 2023. The TGA found SPEVIGO to be effective and well-tolerated, addressing a high unmet medical need in this indication.