Amgen wins new European approval for Uplizna in generalised myasthenia gravis

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Amgen continues to expand the indications for Uplizna (inebilizumab), winning a new European approval for the biologic treatment in generalised myasthenia gravis (gMG).

The European Commission (EC) gave the green light to the product as new, add-on, targeted treatment option for adults who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive.

The biologic has potential to provide long-term disease control via a novel mechanism that selectively targets CD19-positive B cells. These have a key role in the condition’s pathology, according to Dr John Vissing, Professor of Neurology at the University of Copenhagen.

The MINT trial is the largest phase III biologic study assessing AChR+ and MuSK+ patients, and the first to successfully utilise a structured steroid-tapering protocol.  

Notably, additional exploratory endpoint data found that 87.4 percent of participants reduced their steroid dose to 5mg or less per day by Week 26. This reduction was seen in 84.6 of patients in the placebo group.

Cesar Sanz Rodriguez, Vice President of Medical Affairs at Amgen, said: “This approval represents an important advancement for adults with gMG in Europe, helping address debilitating symptoms and potentially reduce the long-term use of steroids where clinically appropriate.

“With convenient twice-yearly dosing and durable efficacy in people with anti‑AChR and anti‑MuSK antibody positive gMG, Uplizna brings a new first-in-class approach to managing this complex disease.”

The monoclonal antibody (mAb) was first approved in Europe in April 2022 as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive.

More recently, it gained a licence in Europe last November as the first treatment for active immunoglobulin G4-related disease (IgG4-RD), an immune-mediated inflammatory disease.

Johnson and Johnson is another big pharmaceutical firm to have secured a novel biologic approval in the EU for generalised myasthenia gravis in recent months. The European Commission authorised J&J’s Imaavy for eligible patients in December 2025.