MEI Pharma Inc. has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for Pracinostat, an investigational drug designed to treat newly diagnosed acute myeloid leukemia (AML) in combination with azacitidine in patients who are 75 years of age or older that are not healthy enough to receive intensive chemotherapy.
MEI has also announced that it has reached an agreement with the FDA regarding the design of its planned Phase III study.
"This designation speaks to both the serious unmet need for AML patients unfit to receive intensive chemotherapy and the promise of Pracinostat to address this need," MEI Pharma President and CEO Daniel P. Gold said. "With this designation, the FDA recognizes that our preliminary clinical data demonstrate that Pracinostat may result in a substantial improvement in the lives of AML patients over available therapy. We have worked closely with the FDA to get to this point and now focus on executing our Phase III study and bringing Pracinostat to market as quickly and efficiently as possible."
MEI received the Breakthrough Therapy Designation due to the data produced by its Phase II Pracniostat plus azacitidine study.
Alerts Sign-up