ARTG Entry
ULTOMIRIS
ARTG entry for ULTOMIRIS (ravulizumab), ARTG 330566 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Alexion Pharmaceuticals
- Active ingredient: ravulizumab
- Therapeutic area: Immunology
What it is
ULTOMIRIS is ravulizumab, a concentrated solution for intravenous infusion supplied in vials of 10 mg/mL, 300 mg in 3 mL, or 1100 mg in 11 mL .
Approved indications
— Treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) . — Atypical haemolytic uraemic syndrome (aHUS) . — Neuromyelitis Optica Spectrum Disorder (NMOSD) . — Generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor antibody positive .
Key safety warnings
No significant safety concerns were identified during TGA evaluation of ULTOMIRIS .
PBS listing
ULTOMIRIS is listed on the PBS with two strengths: 1,100 mg in 11 mL at an ex-manufacturer price of A$24,105.11, and 300 mg in 3 mL at an ex-manufacturer price of A$6,574.12 . Both strengths have authority required restrictions and comprise 18 PBS items each .
Regulatory history
ULTOMIRIS was approved by the TGA on 2019-10-08 for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria . This approval was based on demonstrated non-inferiority to eculizumab with no significant safety or quality concerns, and the drug offers an extended dosing interval compared to eculizumab . In November 2017, PBAC did not recommend ULTOMIRIS for PNH due to uncertainty regarding cost-effectiveness . In July 2021, PBAC recommended ULTOMIRIS for paroxysmal nocturnal haemoglobinuria . In July 2023, PBAC recommended ULTOMIRIS for atypical haemolytic uraemic syndrome following a deferral in March 2023 . In July 2024, PBAC did not recommend ULTOMIRIS for generalised myasthenia gravis in anti-acetylcholine receptor antibody positive adult patients . In November 2024, PBAC recommended ULTOMIRIS for Neuromyelitis Optica Spectrum Disorder for Section 100 Authority Required listing, noting high unmet need, significant improvement in efficacy, and acceptably cost-effective pricing with risk sharing arrangement . In March 2025, PBAC recommended ULTOMIRIS for generalised myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive .