Amgen’s mAb Inebilizumab Approved by European Commission for AChR- and MuSK-Positive Generalized Myasthenia Gravis

The European Commission (EC) has approved the monoclonal antibody (mAb) inebilizumab (Uplizna; Amgen) as an add-on to standard therapy in the treatment of adults with generalized myasthenia gravis (gMG) in adults who are antiacetylcholine receptor (AChR) and antimuscle specific tyrosine kinase (MuSK) antibody positive.¹

The EC’s decision was based on data from the randomized, double-blind, placebo-controlled phase 3 MINT clinical trial (NCT04524273). MINT included 238 patients with gMG who were randomly assigned 1:1 to either intravenous ineblizumab 300 mg (n = 119) or placebo (n = 119) for a 12-month period.² Notably, the study met its primary end point, with a 1.9 point difference seen at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for patients treated with inebilizumab (-4.2) versus patients treated with the placebo (-2.2) (P < .0001).¹ Furthermore, at week 26, investigators recorded statistically significant Quantitative Myasthenia Gravis (QMG) score improvement for inebilizumab compared with placebo (inebilizumab: –4.8 overall improvement; placebo: –2.5; P = .0002).² It was also noted that inebilizumab was well-tolerated, with no new safety signals reported. The most common adverse reactions in patients treated with inebilizumab included headache and infusion-related reactions.³

"Uplizna offers a new approach to treating gMG by selectively targeting CD19-positive B cells, which play a key role in disease pathology," John Vissing, MD, DMSci, a professor of neurology and director of the Copenhagen Neuromuscular Center, Rigshospitalet, at the University of Copenhagen, said in a statement.¹ "The approval provides both clinicians and patients a valuable new treatment option with the potential for long-term efficacy while addressing the challenges of long-term steroid exposure.”

Notably, inebilizumab was previously approved by the EC for adults with active immunoglobulin G4-related disease (IgG4-RD) in November 2025 and for adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive in November 2022.^1,4 In the United States, inebilizumab was approved by the FDA for the treatment of adults with AChR and MuSK antibody positive gMG in December 2025.³ The FDA had likewise previously approved inebilizumab in IgG4-RD and AQP4-IgG-positive NMOSD.

"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," Cesar Sanz Rodriguez, the vice president of Medical Affairs at Amgen, added to the statement.¹ "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."

Notably, at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) meeting, held October 29 to November 1, in San Francisco, California, NeurologyLive®’s sister site CGTLive® spoke to global principal investigator of MINT Richard J. Nowak, MD, MS, the director of the Myasthenia Gravis Clinic and associate professor of neurology at Yale School of Medicine, about 52 week results from the trial that were presented at the conference. In the interview, Nowak highlighted inebilizumab’s demonstration of both efficacy and safety in the available data.

"Patients were also able to enroll in the open-label extension, so we will have additional data forthcoming for up to 3 years of follow-up of patients on [inebilizumab],” Nowak told CGTLive. “I think not only do we have positive results from the phase 3 [MINT] trial and some of the extended time points to date, but we will also have additional open-label extension data in the next 6 to 12 months."

REFERENCES
1. European Commission approves Amgen's Uplizna® for generalized myasthenia gravis. News release. Amgen. February 12, 2026. Accessed February 18, 2026. https://www.amgen.com/newsroom/press-releases/2026/02/european-commission-approves-amgens-uplizna-for-generalized-myasthenia-gravis
2. Amgen Conference Call to Discuss New Topline Data in Inflammation and Rare Disease. News release. Amgen. September 24, 2024. Accessed September 26, 2024. https://amgen2.rev.vbrick.com/#/videos/750c4b9d-5c91-4634-8906-a16b53f346bf.
3. FDA Approves UPLIZNA® For Adults With Generalized Myasthenia Gravis. News release. Amgen. December 11, 2025. Accessed December 12, 2025. https://investors.amgen.com/news-releases/news-release-details/fda-approves-upliznar-adults-generalized-myasthenia-gravis
4. Horizon Therapeutics plc receives European Commission (EC) approval of UPLIZNA® (inebilizumab) for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD). News release. Horizon Therapeutics plc. May 2, 2022. Accessed February 18, 2026. https://www.biospace.com/horizon-therapeutics-plc-receives-european-commission-ec-approval-of-uplizna-inebilizumab-for-the-treatment-of-adults-with-neuromyelitis-optica-spectrum-disorder-nmosd