In this special webinar, Dr. Arlene Chapman reviews the FDA’s response to tolvaptan. Otsuka Pharmaceutical Development & Commercialization, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application for tolvaptan to treat adult patients with ADPKD. The FDA issues CRLs to convey that their initial review of an application is complete and they cannot approve it in its present form. The FDA has requested that Otsuka provide additional information.
To help you understand the FDA’s decision, Dr. Chapman, who serves as a medical advisor to Otsuka for the tolvaptan studies, presents and answers questions. She also talks about other clinical trials that are currently underway. The Foundation’s advocacy initiative to help patients and families share their voices about the need for treatments is also be discussed.
Dr. Chapman holds many titles including Professor of Medicine in the Renal Division at Emory University School of Medicine, Assistant Director of the Renal Fellowship Training Program, Co-Principal Investigator of the Atlanta Clinical and Translational Science Institute, and Program Director Clinical Research Network. She was a member of the Foundation’s Scientific Advisory Committee (SAC) for 10 years, serving as the Chair for two of those, and a member of the Board of Trustees.
Originally aired: September, 2013