Overview

• On 18 September, the EMA’s human medicines committee adopted a positive opinion to extend Uplizna’s authorisation to adults with active IgG4‑related disease.
• In a 52‑week, randomized phase 3 trial of 135 patients, only 7 on Uplizna required treatment for flares versus 40 on placebo, and 58.8% achieved corticosteroid‑free, flare‑free remission at week 52 versus 22.4% on placebo.
• There are no authorised EU treatments for IgG4‑RD, and current care relies on glucocorticoids that frequently cause side effects and are associated with relapses.
• The safety profile in IgG4‑RD was consistent with prior use in NMOSD, with infections, joint pain, back pain and low lymphocyte counts reported most commonly.
• If the Commission approves the extension, Member States will decide pricing and reimbursement, Uplizna will continue under additional monitoring, and the marketing authorisation holder is Amgen Europe B. V.