You are here

FDA Accepts New Drug Application for Kidney Disease Therapy Tolvaptan

Review set for September (Apr. 12)

The FDA has accepted for priority review a new drug application (NDA) for the potential use of tolvaptan (Otsuka Pharmaceutical Co.) for the treatment of autosomal-dominant polycystic kidney disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published online in the New England Journal of Medicine.

ADPKD is a hereditary genetic illness characterized by the development of multiple cysts in the kidneys. It is the most common inherited kidney disease and the fourth most common overall cause of kidney failure worldwide. The diagnosed prevalence is estimated to be between 1:1,000 and 1:4,000 globally.

Tolvaptan is a selective V2 vasopressin receptor antagonist that is believed to slow the progression of ADPKD by reducing the development and growth of kidney cysts. These cysts are characteristic of ADPKD and are often associated with pain, hypertension, decreased kidney function, and, ultimately, kidney failure.

The FDA target action date (PDUFA date) for the new NDA is September 1, 2013.

Source: Otsuka; April 12, 2013.

Recent Headlines

U.S., Australia, and Canada Approve Endometrial Cancer Regimen
Single daily pill combines hypertension, cholesterol drugs
Drug With Androgen Deprivation Therapy Cut Risk of Death by 33% Compared With Placebo + ADT
A Diabetes Drug For People Without Diabetes
Roche Drug Outperformed Standard of Care in Phase 2 Study
Chronic Kidney Patients With Hyperphosphatemia May Be Another Market for the Drug
Nitrosamine Impurity Also Affects Other Ranitidine Drugs
Mesh Implants, Now Banned by FDA, Work as Well as Hysterectomy
One in Five Kids’ Office Visits Results in an Off-Label Rx