Amgen has received US FDA approval for Uplizna (inebilizumab-cdon) to treat adults with generalized myasthenia gravis (gMG) who are AChR- or MuSK-antibody positive.
This approval introduces a new targeted treatment option that offers durable disease control with just two maintenance doses per year after initial loading doses.
Generalized myasthenia gravis is a rare, chronic autoimmune disease that disrupts neuromuscular communication.
Patients often experience:
In the US alone, gMG affects 80,000–100,000 people, with limited long-term treatment options.
Uplizna is a humanized monoclonal antibody that targets CD19-positive B cells, which produce harmful autoantibodies in gMG.
By depleting these B cells, Uplizna addresses a root cause of disease, rather than only managing symptoms.
Key advantages include:
The FDA approval is based on results from the MINT Phase 3 trial, the largest biologic study conducted in gMG.
MINT was the first gMG trial to require steroid tapering.
By Week 26:
Uplizna was generally well tolerated. The most common side effects were:
No new safety concerns were identified during the trial.
This marks the third FDA-approved indication for Uplizna.
Previous approvals include:
The gMG approval further strengthens Amgen’s presence in rare autoimmune diseases.
With Uplizna, patients gain:
For people living with gMG, this approval represents six months of treatment-free time between maintenance doses.
The FDA approval of Uplizna introduces a first-in-class, B-cell–targeted therapy for generalized myasthenia gravis.
It expands treatment options, simplifies dosing, and addresses the disease at a biological level—offering meaningful progress for patients and clinicians alike.