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NDSU expert serves on FDA advisory panel


Donald Miller, professor and chair of the Department of Pharmacy Practice at NDSU, recently served on a Food and Drug Administration Arthritis Advisory panel.

The panel of independent experts reviewed and evaluated data on the safety and effectiveness of the prescription drugs Cimzia and Humira as treatment for spondyloarthritide disorders, or inflammatory back arthritis. The panel then made a recommendation to the FDA on whether it should approve the drugs to be labeled and advertised as treatment for the disorders.

Miller, an expert on arthritis medications, was nominated to serve on the advisory panel by the American College of Rheumatology. He served alongside doctors, pharmacists and public health experts from institutions such as Tufts University School of Medicine, Yale School of Public Health, Newark Beth Israel Hospital, Johns Hopkins University School of Medicine and Bloomberg School of Public Health, Harvard Medical School and the National Institutes of Health.

“It was great intellectual exercise to debate with other experts in the field and see the FDA process up close,” Miller said.

Cimzia and Humira already are approved to treat rheumatoid arthritis and other conditions. The panel recommended the FDA approve Cimzia as a treatment for spondyloarthritide disorders as well. If the FDA supports the recommendation, the Belgian pharmaceutical company UCB will be authorized to label and advertise Cimzia as a treatment for the disorders.

The panel recommended against the FDA approving Humira for an additional use. According to Reuters, the panel suggested AbbVie Pharmaceuticals conduct an additional clinical trial to support its effectiveness as a treatment for spondyloarthritide disorders. Doctors, however, still are permitted to prescribe Humira as an “off label” treatment for the disorders.

NDSU is recognized as one of the nation’s top 108 public and private universities by the Carnegie Commission on Higher Education.

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