Written Testimonies Needed for FDA Advisory Committee Review of Tolvaptan
On August 5, the Food and Drug Administration (FDA) Advisory Committee for Cardiovascular and Renal Drugs will be holding a special meeting to discuss the new drug application for tolvaptan as a potential treatment for ADPKD. At this meeting, in addition to testimony from researchers and clinicians, the committee will also hear presentations from the public. The PKD Foundation has submitted the names of several individuals who can speak about the burden of having PKD and the impact on generation after generation of families. They will also be testifying that a pharmaceutical treatment option is long overdue, and that dialysis and transplantation shouldn’t be the only options for people with ADPKD.
You too can make an impact by submitting your story in writing! The FDA will be accepting written testimonies through Monday, July 22. To testify to the committee in writing, please send your submission describing the burden PKD has placed on you and your family to the contact below. If you’ve had a difficult experience with dialysis or transplantation, please share your story to help reinforce the point that PKD patients need treatment options to prevent dialysis and transplantation.
Kristina A. Toliver, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Telephone: (301) 796-9001
Fax: (301) 847-8533
This committee will review all testimonies and make a recommendation to the FDA, who will make a final decision about tolvaptan. The FDA’s goal is to have a decision by September 1.
To learn more about this meeting and tolvaptan, visit: