Ultomiris (ravulizumab-cwvz) — Medica
Generalized myasthenia gravis (gMG)
Initial criteria
- age ≥ 18 years
- Confirmed anti-acetylcholine receptor antibody-positive generalized myasthenia gravis
- Myasthenia Gravis Foundation of America classification II to IV
- Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6
- Patient previously received or is currently receiving pyridostigmine OR had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine
- Patient previously received or is currently receiving two different immunosuppressant therapies for ≥ 1 year OR had inadequate efficacy, a contraindication, or significant intolerance to two different immunosuppressant therapies (e.g., azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus, cyclophosphamide)
- Evidence of unresolved symptoms of generalized myasthenia gravis
Approval duration
6 months