Ulcerative Colitis: The Complete Guide to Medical Management

Gary R. Lichtenstein, MD, FACP, FACG, AGAF

Chapter 3: The Role of the FDA in Drug Development in Inflammatory Bowel Disease (continued)

Alan C. Moss, MD, FACG; Adam S. Cheifetz, MD

THE ROLE OF THE FDA IN DRUG DEVELOPMENT IN INFLAMMATORY BOWEL DISEASE Inflammatory bowel disease (IBD) affects approximately 1 million individuals in the United States and 4 million people worldwide, the majority of whom are prescribed medication for induction or maintenance of remission. At any point in time, more than 75% of patients with IBD are taking prescription medication, which is 3 times higher than the non-IBD population.1 In addition to standard therapies, developments in molecular biology have identified many novel therapeutic targets that will add to the patient’s…