- Amgen Canada has launched Uplizna (inebilizumab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who test positive for anti-AChR or anti-MuSK antibodies.
- Uplizna targets CD19-positive B cells, addressing an underlying driver of gMG. Following two initial loading doses, patients receive maintenance treatment twice yearly, offering a less frequent dosing schedule.
- Health Canada’s authorization is supported by the Phase 3 MINT trial, which included both antibody-positive patient groups and a structured steroid-tapering protocol. By Week 26, 87.4% of Uplizna-treated patients had reduced prednisone to 5 mg or less daily.
- The launch expands Uplizna’s Canadian use beyond neuromyelitis optica spectrum disorder and IgG4-related disease. Amgen’s Entrust Rare Patient Support Program will provide eligible patients with personalized assistance throughout treatment.
Takeaways:
Amgen Canada’s Uplizna launch expands its immunology franchise into gMG, competing in a market increasingly focused on targeted therapies and reduced treatment burden. Twice-yearly maintenance dosing and steroid-tapering data may support differentiation across anti-AChR- and anti-MuSK-positive patients, while patient support could help address access and treatment-adherence barriers.
Source: Amgen
