#Amgen #Thousand Oaks #Czech Republic #Myasthenia Gravis #UPLIZNA

Amgen’s UPLIZNA® Secures European Approval for Myasthenia Gravis Treatment

On February 13, 2026, Amgen (NASDAQ: AMGN) made a significant announcement regarding the approval of UPLIZNA® (inebilizumab) by the European Commission (EC) as an adjunct therapy for adults suffering from generalized myasthenia gravis (gMG). This highly specialized treatment targets patients who test positive for acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibodies, marking a pivotal moment in the management of this complex autoimmune disorder.

Significance of the Approval

Generalized myasthenia gravis is a rare and unpredictable chronic autoimmune disease mediated by B-cells. It leads to fluctuating muscle weakness, significantly impacting patients' lives. This condition affects an estimated 56,000 to 123,000 individuals across Europe, making effective management crucial.

The approval for UPLIZNA® represents an important step forward in therapy. The treatment allows for a regimen of just two doses per year after an initial loading phase, providing patients with a practical and efficient option to manage their symptoms. Cesar Sanz Rodriguez, Vice President of Medical Affairs at Amgen, highlighted the potential for this treatment to alleviate debilitating symptoms and potentially reduce long-term steroid use when clinically appropriate.

Clinical Study Support

The EC's decision is strongly supported by data from the Myasthenia Gravis Inebilizumab Trial (MINT), a comprehensive Phase 3 study that showcased UPLIZNA's effectiveness. The study included 238 adult participants, including both AChR+ and MuSK+ patients, and implemented a structured steroid dose reduction protocol.

Within just four weeks of starting treatment with UPLIZNA, patients began tapering their steroid doses with the aim of reaching a daily dose of 5 mg by week 24. Impressively, 87.4% of UPLIZNA patients achieved this reduction compared to 84.6% in the placebo group, demonstrating the drug's efficacy and patients' response.

Mechanism of Action

Dr. John Vissing, a neurologist and director at Copenhagen's neuromuscular center, explained the innovative mechanism behind UPLIZNA. By selectively targeting CD19-positive B-cells crucial to the disease's pathology, UPLIZNA offers an effective way to manage gMG while addressing complications related to long-term steroid exposure. This approved therapy not only opens new avenues for patients but also empowers healthcare providers with a valuable option for managing an otherwise challenging condition.

Previous Successes

UPLIZNA's approval for gMG builds on its proven efficacy in treating rare autoimmune diseases, having previously been approved in November 2025 for adult patients with immunoglobulin G4-related disease (IgG4-RD) and earlier for neuromyelitis optica spectrum disorder (NMOSD). Regulatory bodies outside Europe, including the FDA and Health Canada, have recognized UPLIZNA for multiple indications, solidifying its place as a crucial therapeutic in chronic autoimmune disease management.

Conclusion

Overall, the European Commission's approval of UPLIZNA for generalized myasthenia gravis is a groundbreaking step towards improving the quality of life for affected patients. With its practical dosing schedule and potential for long-term control of the disease, UPLIZNA brings hope to many individuals grappling with the complex challenges of gMG. As Amgen continues to innovate within the biopharmaceutical sphere, UPLIZNA stands as a testament to the company's commitment to addressing unmet medical needs.

For more information about UPLIZNA and Amgen's initiatives, visit Amgen's website.