EMA’s human medicines committee (CHMP) has recommended extending the therapeutic indication of Uplizna (inebilizumab) to include the treatment of adult patients with active immunoglobulin G4-related disease (IgG4-RD).

IgG4-RD is a rare, chronic, autoimmune condition (a disease caused by the body’s own defence system attacking normal tissue) that can cause fibrosis (tissue scarring) and inflammations in one or multiple organs. Patients with IgG4-RD suffer from new or worsening signs and symptoms in one or more organs. The consequences of inflammation manifest gradually or acutely and can lead to irreversible organ damage and dysfunction. IgG4-RD normally affects people between the ages of 40 and 60.

There are currently no authorised medicines in the EU for the treatment of adults with IgG4-RD, and patients are commonly treated with glucocorticoids and other immunomodulatory medicines. Some patients show significant reductions in the size of lesions and improvement in laboratory…