Alexion Pharmaceuticals

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Clinical Data

Alexion conducted three multi-national clinical studies of Soliris involving nearly 200 patients with PNH, a substantial population given the rareness of the disease.18,19,26 These Phase III trials were widely reported at major medical meetings and published in the New England Journal of Medicine and the journal Blood.18-20 For additional details, please see our overview of Phase III trials. In these trials, patients with PNH who received Soliris experienced a number of benefits, including:

  • Immediate and sustained reduction in chronic hemolysis in all patients 18,19
  • Fewer thrombotic events (blood clots) as compared to the same time period prior to starting Soliris24
  • Significant improvements in fatigue levels and overall quality of life 18,19
  • Significant reduction in the need for transfusions19

Further analysis of this clinical data has shown that patients with PNH have a high rate of chronic kidney disease and pulmonary hypertension. Researchers also observed a reduction in chronic kidney disease and pulmonary hypertension in patients with PNH who received Soliris therapy. Learn more about this clinical research.



IMPORTANT SAFETY INFORMATION

Soliris increases the risk of meningococcal infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early

Soliris® increases the risk of meningococcal infections

  • Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use
  • Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary

The effect of anticoagulant withdrawal during Soliris treatment has not been studied. Therefore, treatment with Soliris should not alter anticoagulant management.

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, a runny nose (nasopharyngitis), back pain, nausea, and tiredness (fatigue).

Please see full Prescribing Information and Important Safety Information for Soliris® (eculizumab).