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Research Letter
October 28, 2019

The Clinical Trials Portfolio for On-label and Off-label Studies of Eculizumab

Author Affiliations
  • 1Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland
  • 2Department of Public Health and Preventive Medicine, Oregon Health and Science University, Portland
  • 3Center for Health Care Ethics, Oregon Health and Science University, Portland
JAMA Intern Med. 2020;180(2):315-317. doi:10.1001/jamainternmed.2019.4694

Eculizumab is a monoclonal antibody against complement C5 that is manufactured by Alexion Pharmaceuticals. It first received US Food and Drug Administration (FDA) approval in 2007 for treatment of paroxysmal nocturnal hemoglobinuria, a rare disease with incidence of 1 to 10 per million and, when it debuted, was the most costly drug in the world, priced at $400 000 per year for indefinite use.1,2

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