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