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European Commission Approves UPLIZNA® by Amgen for Generalized Myasthenia Gravis

On February 12, 2026, Amgen (NASDAQ:AMGN) announced a significant advancement in the treatment of generalized myasthenia gravis (gMG) with the European Commission's approval of UPLIZNA® (inebilizumab). This groundbreaking therapy is a crucial addition as a complementary treatment for adult patients who have gMG with acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibodies.

A New Hope for Patients

Generalized myasthenia gravis is a chronic autoimmune disorder that causes severe muscle weakness and fluctuating symptoms, greatly impacting sufferers’ quality of life. In Europe, approximately 56,000 to 123,000 individuals are living with gMG, emphasizing the urgent need for effective treatment options. UPLIZNA® offers a unique mechanism that targets CD19-positive B-cells, which are vital contributors to the disease's pathology. The therapy provides a promising avenue for patients, as it enables a new path towards long-term disease control leveraging a semi-annual dosing schedule after an initial loading phase.

César Sanz Rodríguez, Vice President of Medical Affairs at Amgen, remarked on the importance of this approval, stating, "This is a major breakthrough for adults with gMG in Europe, helping manage debilitating symptoms while potentially reducing the long-term use of steroids when clinically suitable."

Key Findings from Clinical Trials

The approval of UPLIZNA® was supported by results from the Phase 3 MINT trial, which stands as the largest biological study assessing the efficacy of inebilizumab for gMG patients with anti-AChR and anti-MuSK positivity. The trial demonstrated how the treatment not only effectively reduced symptoms but also offered a practical approach to minimize steroid intake. Within the study, an impressive 87.4% of patients on UPLIZNA® successfully tapered their steroid dosage to 5mg or less compared to 84.6% on placebo by week 26.

Dr. John Vissing, a prominent neurologist from Copenhagen, highlighted that UPLIZNA® represents a paradigm shift in gMG treatment by focusing on B-cells. He noted, "With this approval, patients and healthcare providers now have access to a novel therapeutic option that holds the promise for long-term efficacy and tackles the challenges posed by prolonged steroid exposure."

Mechanism of Action and Dosing

UPLIZNA® is a humanized monoclonal antibody that directly targets and depletes pathogenic B-cells, effectively halting the disease's progression at a cellular level. After the initial two infusions, it requires maintenance doses every six months—an appealing feature for many patients seeking a manageable treatment regime.

Broader Implications and Recognition

Beyond gMG, UPLIZNA® has previously gained approval for other rare autoimmune disorders, including IgG4-related disease and neuromyelitis optica spectrum disorder (NMOSD). The regulatory endorsement for diverse conditions signifies its potential versatility and efficacy across autoimmune pathologies.

Amgen's commitment to innovation has kept it at the forefront of biopharmaceutical developments, consistently recognized for its contributions to healthcare and the development of groundbreaking treatments targeting some of the most challenging diseases.

For more insights and updates, the Amgen website and their social media channels provide extensive information about UPLIZNA® and other ongoing initiatives in the fight against autoimmune disorders.

By offering a fresh perspective on managing a debilitating condition like generalized myasthenia gravis, Amgen’s UPLIZNA® could change lives, paving a new way for those suffering from this chronic condition.