The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended extending the therapeutic indication of Amgen Inc.’s 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 inflammation in one or multiple organs.

There are currently no authorised medicines in the EU for adults with IgG4-RD, and patients are commonly treated with glucocorticoids and other immunomodulatory medicines.

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Uplizna contains inebilizumab, a monoclonal antibody (a type of protein) that attaches to immune cells called B cells and destroys them. Uplizna is already approved to treat patients with neuromyelitis optica spectrum disorders (NMOSD).

The CHMP based its recommendation on the assessment of efficacy and safety data from a phase 3 trial in 135 adult patients with active IgG4-RD who received either intravenous Uplizna or matching placebo on day 1, day 15, and week 26.

The median time to the first treated IgG4-RD flare was significantly longer in patients receiving Uplizna.

Similarly, of the 68 patients receiving Uplizna, only seven were treated for IgG4 RD flares, compared to 40 of the 67 patients receiving placebo.

In addition, 58.8% of patients receiving Uplizna achieved corticosteroid-free, flare-free complete remission (a period without disease symptoms after treatment) at week 52, compared to 22.4% of patients receiving placebo.

Price Action: AMGN stock was trading higher by 2.69% to $283.26 at last check Friday.

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