Otsuka Pharmaceuti1xbet 로그인l Co., Ltd.
February 12, 2020
Otsuka announces that subsidiary Astex Pharmaceuticals' NDA for ASTX727 (oral C-DEC), for t1xbet 로그인 treatment of MDS and CMML, has been accepted for priority review by t1xbet 로그인 U.S. FDA
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., has been informed by t1xbet 로그인 U.S. Food and Drug Administration (FDA) that t1xbet 로그인 agency has accepted for priority review Astex's new drug application (NDA) for oral C-DEC, a combination of t1xbet 로그인 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).
T1xbet 로그인 NDA submission is supported by data from t1xbet 로그인 ASCERTAIN phase 3 study.
T1xbet 로그인 FDA grants t1xbet 로그인 Priority Review Designation to applications for drugs that, if approved, would provide significant improvements in t1xbet 로그인 safety and effectiveness of t1xbet 로그인 treatment, diagnosis or prevention of serious conditions.
T1xbet 로그인 Priority Review Designation means that t1xbet 로그인 FDA's goal is to take action on an NDA application within six months (compared to t1xbet 로그인 ten months under standard review).
Oral C-DEC is an investigational compound and is not currently approved in any country.