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Ravulizumab-cwvz

(Ultomiris®)

Ultomiris®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 300 mg/30 mL [10 mg/mL], 300 mg/3 mL [100 mg/mL], 1,100 mg/11 mL [100 mg/mL])
Drug ClassComplement inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH)
  • Indicated for the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA)
  • Indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive
  • Indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

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Summary
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • The studies involved general populations with Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), and Myasthenia Gravis (MG), with PNH patients treated with complement inhibitors and aHUS patients showing a higher risk of recurrence associated with genetic mutations (complement factor I (CFI), membrane cofactor protein (MCP), and complement factor H (CFH)). Additionally, 40% of aHUS patients are under 18 years old.
  • In aHUS, the identification of genetic mutations necessitates prompt initiation of monoclonal antibody treatment to mitigate recurrence risks, emphasizing the importance of genetic screening in this population.
  • The findings also indicate that the general MG population is treated with innovative therapies, including complement inhibitors and FcRn blockers, suggesting a shift toward personalized treatment approaches based on individual patient needs.
  • In PNH, no specific safety outcomes were highlighted for ravulizumab compared to other drugs, indicating a lack of detailed safety data.
  • In aHUS, serious adverse events occurred in 42% of patients treated with Eculizumab, along with two cases of meningococcal infection. Ravulizumab was associated with four deaths (7%) after 26 weeks, but no specific adverse events were mentioned in the study.
  • There is no population type or subgroup information available in the reviewed studies.