Tolvaptan Special Update: Accepted for Priority Review by FDA

A major announcement was made recently by Otsuka Pharmaceutical Co., Ltd. that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the company's new drug application (NDA) for the potential use of tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD).

The FDA's goal for reviewing a drug with Priority Review status is six months from the NDA submission date. The FDA target action date (PDUFA date) for this NDA is September 1, 2013.

The Foundation funded early preclinical animal testing of tolvaptan, the precursor to the human clinical trials that showed positive results in slowing the progression of PKD. The results of the Phase III clinical trial results that formed the basis of the regulatory filing were published in the New England Journal of Medicine in November.

If approved, tolvaptan will become the first pharmaceutical therapy for patients with ADPKD.

View or download the official press release from Otsuka Pharmaceutical Co., Ltd.
Visit Otsuka's website
Read an earlier announcement about the results of the Phase III clinical trial
Learn how to submit your testimonial for the FDA Advisory Committee's review of tolvaptan

Your Organization

2000 Daniel Island Drive, Charleston SC 29492
Phone: 800.443.9441 | Fax: 843.216.6100
info@yourdomain.org

©2014, PKD Foundation ·The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.

©2014, PKD Foundation ·The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.

The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.
National Headquarters: 8330 Ward Parkway, Suite 510, Kansas City, MO 64114. Phone: 1.800.PKD.CURE
©2014 PKD Foundation. Privacy Policy | Terms & Conditions

Founded in 1982, our vision is that one day,
no one will suffer the full effects of polycystic kidney disease.


International: Canada Canada  France France  Germany Germany  Italy Italy  Japan Japan  United Kingdom United Kingdom