February 12, 2020
Otsuka Pharmaceutical Co., Ltd.
Otsuka announces that subsidiary Astex Pharmaceuticals' NDA for ASTX727 (oral C-DEC), for the treatment of MDS and CMML, has been accepted for priority review by the U.S. FDA
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., has been informed by the U.S. Food and Drug Administration (FDA) that the agency has accepted for priority review Astex's new drug application (NDA) for oral C-DEC, a combination of the oral hypomethylating agent cedazuridine and decitabine.
Oral C-DEC is in development as a treatment for adults with previously untreated intermediate- and high-risk myelodysplastic syndrome (MDS), including chronic myelomonocytic leukemia (CMML).
The NDA submission is supported by data from the ASCERTAIN phase 3 study.
The FDA grants the Priority Review Designation to applications for drugs that, if approved, would provide significant improvements in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions.
The Priority Review Designation means that the FDA's goal is to take action on an NDA application within six months (compared to the ten months under standard review).
Oral C-DEC is an investigational compound and is not currently approved in any country.
Information in this news release was current as of the original release date.