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Otsuka's NDA for Tolvaptan for Autosomal Dominant Polycystic Kidney Disease , Accepted for Review by FDA

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Otsuka Pharmaceutical Co (OTC: OTSKY) announced today 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). Phase
III clinical trial results that form the basis of the regulatory filing
were published online in the New England Journal of Medicine.1

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

See full press release

Posted-In: Earnings News Guidance Global

 

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